Blood contaminant sequestration device with one-way air valve and air-permeable blood barrier with closure mechanism

ABSTRACT

Blood sample optimization systems and methods are described that reduce or eliminate contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. A blood sample optimization system can include a blood sequestration device located between a patient needle and a sample needle. The blood sequestration device can include a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.

BACKGROUND

Bacteraemia is the presence of microorganisms in the blood. Sepsis, onthe other hand, is bacteraemia in the presence of clinical symptoms andsigns such as fever, tachycardia, tachypnea and hypotension. Bacteraemiaand sepsis are associated with a high mortality and an increasedincidence and duration of hospital stay and associated costs. Manybacteraemias, sepsis, fungaemias and other pathogens actually occurwithin a hospital or other healthcare settings with catheters andvenipunctures being a source of contamination as potential carriers ofthese pathogens.

Blood cultures are the standard test used to detect microbial pathogensrelated to bacteraemia and sepsis in a patient's blood. The term bloodculture refers to a single venipuncture, either from a peripheral siteor central or arterial line, with the blood inoculated into one or moreblood culture bottles or containers. One bottle is considered a bloodculture where two or more are considered a set. Multiple sets may beobtained from multiple venipunctures and are associated with differentsites on the patient.

These methods allow for microbial identification and susceptibilitytesting to be performed, which is a critical component to managingsepsis, however the lack of rapid results and decreased sensitivity forfastidious pathogens has led to the development of improved systems andadjunctive molecular or proteomic testing.

Collection of blood samples for conducting blood cultures is a criticalcomponent of modern patient care and can either positively affect thepatient outcome by providing an accurate diagnosis, or can adverselyaffect the outcome by prolonging unnecessary antimicrobial therapy, thelength of hospital stays, and increasing costs.

One outcome of collection of blood cultures is contamination. Bloodculture contamination can lead to a false positive culture result and/orsignificant increase in healthcare related costs. Sources of bloodculture contamination include improper skin antisepsis, impropercollection tube disinfection, and contamination of the initial blooddraw which may then skew results.

Blood culture collection kits generally consist of a “butterfly” set,infusion set, or other type of venipuncture device as offered bycompanies like BD, Smiths, B. Braun and others, and aerobic andanaerobic blood culture bottles. Various different bottles are alsoavailable depending on the test requirements. These bottles arespecifically designed to optimize recovery of both aerobic and anaerobicorganisms. In conventional kits, a bottle used is known generally as a“Vacutainer,” which is a blood collection tube formed of a sterile glassor plastic tube with a closure that is evacuated to create a vacuuminside the tube to facilitate the draw of a predetermined volume ofliquid such as blood.

False positive blood cultures are typically a result of poor samplingtechniques. They cause the use of antibiotics when not needed,increasing hospital costs and patient anxiety. Blood cultures are drawnfrom a needlestick into the skin, and then a Vacutainer is attached tocapture a sample of blood. Contamination may occur from improper orincomplete disinfection of the skin area in and around the puncturesite. It may also occur from the coring of the skin by the needle duringinsertion, with the cored skin cells and any associated contaminationbeing pulled into the sample.

Blood flow through a hypodermic needle is laminar, and as such, avelocity gradient can be developed over the flow tube as a pressure dropis applied to the hypodermic needle. Either forceful aspiration ofblood, or using a very small hypodermic needle, can cause lysis and arelease of potassium from the red blood cells, thereby rendering theblood samples abnormal.

In other instances, some patients have delicate veins that can collapseunder a pressure drop or vacuum, particularly as applied by a syringe'splunger that is drawn too quickly for the patient's condition. Sincesuch condition is impossible to know beforehand, such vein collapses area risk and very difficult to control.

Various strategies have been implemented to decrease blood culturecontamination rates, e.g. training staff with regard to asepticcollection technique, feedback with regard to contamination rates andimplementation of blood culture collection kits. Although skinantisepsis can reduce the burden of contamination, 20% or more of skinorganisms are located deep within the dermis and are unaffected byantisepsis. Changing needles before bottle inoculation is not advisableas it increases the risk to acquire needle stick injuries withoutdecreasing contamination rates.

Some conventional systems and techniques for reducing blood culturecontamination include discarding the initial aliquot of blood taken fromcentral venous catheters, venipunctures, and other vascular accesssystems. However, these systems require the user to mechanicallymanipulate an intravascular device, or require a complex series of stepsthat are difficult to ensure being followed.

SUMMARY

This document presents systems and methods for reducing blood culturecontamination, lysing of cells, and vein collapse. In someimplementations, a system and method can eliminate user variability indisinfection, and also eliminate the risk of skin cells getting into theblood culture sample. The systems and methods disclosed herein do notrequire a change in existing clinical processes, other than topotentially indicate when a vacutainer or other blood collection device(i.e., syringe) should be attached for drawing contaminant-free bloodsamples.

In some implementations of the systems and methods disclosed herein thewithdrawal of blood is accomplished passively by use of the patient'sown blood pressure, thereby reducing the risk of vein collapse andeliminating any additional user steps over current practice. The systemsand methods can be applied to accommodate short-path direct stick orbutterfly venipuncture systems. They can also be used with samples drawnthrough a catheter.

In one aspect, a blood sequestration device is presented. The bloodsequestration device includes an inlet port and an outlet port. Theblood sequestration device further includes a sequestration chamberconnected with the inlet port, the sequestration chamber having a ventcomprising an air permeable blood barrier. The blood sequestrationdevice further includes a sampling channel having a proximal endconnected with the inlet port and a distal end connected with the outletport.

In another aspect, a blood sequestration device connected with a bloodsampling pathway is described. The blood sampling pathway has a patientneedle and a sample collection device. The blood sequestration deviceincludes an inlet port connected with the patient needle, and asequestration chamber connected with the inlet port, the sequestrationchamber having a vent comprising an air permeable blood barrier. Theblood sequestration device further includes a sampling channel having aproximal end connected with the inlet port, and an outlet port connectedwith a distal end of the sampling channel and with the sample collectiondevice.

In yet another aspect, a blood sequestration device connected with ablood sampling system is described. The blood sampling system includes apatient needle for accessing a blood sample from a patient, and a sampleneedle that is sealed and adapted for receiving an evacuated bloodcollection tube. The blood sequestration device includes an inlet portconnected with the patient needle to receive the blood sample from thepatient. The blood sequestration device further includes a sequestrationchamber connected with the inlet port and having a vent comprising anair permeable blood barrier, the sequestration chamber for receiving andsequestering a first portion of the blood sample prior to the sampleneedle being unsealed by the evacuated blood collection tube. The bloodsequestration device further includes a sampling channel having aproximal end connected with the inlet port, the sampling channel forconveying a subsequent portion of the blood sample once the sampleneedle is unsealed by the evacuated blood collection tube. The bloodsequestration device further includes an outlet port connected with adistal end of the sampling channel for conveying the subsequent portionof the blood sample to the sample needle.

In yet another aspect, a blood sample optimization system is disclosedand described. The blood sample optimization system includes a bloodsampling system for accessing and acquiring one or more samples of apatient's blood, and a blood sequestration device for receiving andsequestering a first portion of the one or more samples of the patient'sblood which might be contaminated by a venipuncture process and whichcould result in a false positive identification of a pathogen in thepatient's blood.

The blood sampling system includes a patient needle configured for avenipuncture of a patient to access a sample of blood of a patient, ablood sampling pathway connected with the patient needle for conveyingthe sample of blood, and a sample needle configured for receiving anevacuated blood collection container to collect and contain a subsequentportion of the sample of blood.

In yet another aspect, a blood sequestration device is disclosed anddescribed. In some implementations, the blood sequestration device caninclude an inlet port, an outlet port connected with the inlet port, anda sequestration chamber connected with the inlet port. The sequestrationchamber can have a vent comprising an air permeable blood barrier.

The blood sequestration device is connected along the blood samplingpathway between the patient needle and the sample needle, and includesan inlet port for receiving the sample of blood. The blood sequestrationdevice further includes a sequestration chamber connected with the inletport for receiving a first amount of the sample of blood, thesequestration chamber having a vent comprising an air permeable bloodbarrier for sequestering at least a first portion of the first amount ofthe sample of blood. The blood sequestration device may further includea sampling channel having a proximal end connected with the inlet port,the sampling channel conveying a subsequent amount of the sample ofblood to the evacuated blood collection container upon the sequestrationchamber sequestering at least the first portion of the first amount ofthe sample of blood. The blood sequestration device further includes anoutlet port connected with a distal end of the sampling channel, theoutlet port for outputting the subsequent amount of the sample of blood.

The details of one or more embodiments are set forth in the accompanyingdrawings and the description below. Other features and advantages willbe apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with referenceto the following drawings.

FIG. 1 illustrates a blood sample optimization system.

FIG. 2 illustrates a blood sample optimization system in accordance withan alternative implementation.

FIG. 3 illustrates a blood sample optimization system in accordance withanother alternative implementation.

FIG. 4 illustrates a blood sample optimization system in accordance withanother alternative implementation.

FIG. 5 illustrates a blood sample optimization system in accordance withanother alternative implementation.

FIG. 6 illustrates a blood sample optimization system in accordance withan alternative implementation.

FIG. 7 is a flowchart of a method for optimizing a quality of a bloodculture.

FIGS. 8A-8E illustrate a blood sequestration system for non-contaminatedblood sampling, in accordance with some implementations.

FIG. 9 illustrates a pathway splitter for use in a blood sequestrationssystem.

FIGS. 10A-10D illustrate a blood sequestration system fornon-contaminated blood sampling, in accordance with alternativeimplementations.

FIGS. 11A-11E illustrate a blood sequestration system fornon-contaminated blood sampling, in accordance with other alternativeimplementations.

FIGS. 12A-12D illustrate a blood sample optimization system including ablood sequestration device in accordance with yet other alternativeimplementations.

FIGS. 13A-13D illustrate a blood sample optimization system 1300 inaccordance with yet another alternative implementations.

FIGS. 14A-14E illustrate yet another implementation of a blood samplingsystem to sequester contaminates of an initial aliquot or sample toreduce false positives in blood cultures or tests performed on apatient's blood sample.

FIGS. 15A-15G illustrate a blood sequestration device and method ofusing the same, in accordance with yet another implementation.

FIGS. 16A-16D illustrate a blood sequestration device in accordance withyet another implementation.

FIGS. 17A-17E illustrate a bottom member of a housing for a bloodsequestration device.

FIGS. 18A-18F illustrate a top member of a housing for a bloodsequestration device.

FIGS. 19A and 19B illustrate a blood sequestration device having a topmember mated with a bottom member.

FIG. 20 shows a blood sample optimization system including a bloodsequestration device.

FIG. 21 illustrates a non-vented blood sequestration device using awicking material chamber.

FIGS. 22A and 22B illustrate a material makeup of a filter forsequestering blood in a sequestration chamber of a blood sequestrationdevice.

FIGS. 23A-23E illustrate another implementation of a blood sequestrationdevice that uses a vacuum force from a blood collection device.

FIGS. 24A-24D illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIGS. 25A-25D illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIGS. 26A-26E illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIGS. 27A-27D illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIGS. 28A-28F illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIGS. 29A-29C illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIGS. 30A-30G illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIGS. 31A-31E illustrate another implementation of a blood optimizationsystem and blood sequestration device.

FIG. 32 illustrates a blood sequestration device having a one-way valve.

FIGS. 33A-33B illustrate an implementation of a one-way valve for aventing mechanism of a sequestration chamber of a blood sequestrationdevice.

FIG. 34 illustrates another implementation of a blood sequestrationdevice having a one-way valve.

FIG. 35 illustrates another implementation of a one-way valve for aventing mechanism of a sequestration chamber of a blood sequestrationdevice.

FIGS. 36A-36D illustrate a blood sequestration device having amanually-actuated closure mechanism.

FIGS. 37A-37E illustrate another implementation of a blood sequestrationdevice having a manually-actuated closure mechanism.

FIGS. 38A-38D illustrate yet another implementation of a bloodsequestration device having a manually-actuated closure mechanism.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

This document describes blood sample optimization systems and methodsfor reducing or eliminating contaminates in collected blood samples,which in turn reduces or eliminates false positive readings in bloodcultures or other testing of collected blood samples. In someimplementations, a blood sample optimization system includes a patientneedle for vascular access to a patient's bloodstream, a sample needlefor providing a blood sample to a blood collection container, such as anevacuated blood collection container or tube like a Vacutainer™ or thelike, or other sampling device, and a blood sequestration device locatedbetween the patient needle and the sample needle. The bloodsequestration device includes a sequestration chamber for sequesteringan initial, potentially contaminated aliquot of blood, and may furtherinclude a sampling channel that bypasses the sequestration chamber toconvey likely uncontaminated blood between the patient needle and thesample needle after the initial aliquot of blood is sequestered in thesequestration chamber.

In some implementations, a blood sequestration device includes adiverter junction that is configured such that the flow out of an inletport from the patient needle or tubing thereto flows first to, ispreferentially directed toward, or is biased toward the sequestrationchamber. For instance, the diverter junction can be configured or formedsuch that a first portion of blood follows a path of least resistancetoward the sequestration chamber. The blood sequestration device can useother types of diverters, junctions or flow-biasing mechanisms. Thesequestration chamber may also include or form a curve or ramp to createthe path of least resistance and direct the initial blood flow towardand into the sequestration chamber, regardless of any positioning ororientation of the blood sequestration device.

FIG. 1 illustrates a blood sample optimization system in accordance withsome implementations. The system includes a patient needle 1 to puncturethe skin of a patient to access the patient's vein and blood therein.The system further includes a sample needle (i.e., a resealably closedneedle for use with Vacutainers™ or the like) 5, which may be containedwithin and initially sealed by a resealable boot 10, a Luer activatedvalve, or another collection interface or device. The resealable boot 10can be pushed aside or around the sample needle 5 by application of aVacutainer™ bottle (not shown) for drawing the patient's blood. Thesystem can further include a low volume chamber 30 that leads to thesample needle 5, but also includes an orifice or one or more channels 45that lead to a sequestration chamber 55 formed by a housing 50.

The sequestration chamber 55 is a chamber, channel, pathway, lock, orother structure for receiving and holding a first aliquot of thepatient's blood, which may be in a predetermined or measured amount,depending on a volume of the sequestration chamber 55. The first draw ofblood typically contains or is more susceptible to containing organismsthat cause bacteraemia and sepsis or other pathogens than subsequentblood draws. The sequestration chamber 55 can be a vessel encased in asolid housing, formed in or defined by the housing itself, or can beimplemented as tubing or a lumen. The sequestration chamber 55,regardless how formed and implemented, may have a predetermined volume.In some implementations, the predetermined volume may be based on avolume of the patient needle, i.e. ranging from less than the volume ofthe patient needle to any volume up to or greater than 20 times or moreof the volume of the patient needle. The predetermined volume of thesequestration chamber 55 may also be established to economize orminimize an amount of blood to be sequestered and disposed of

The sequestration chamber 55 can be formed, contained or housed in achamber housing 50, and can be made of plastic, rubber, steel, aluminumor other suitable material. For example, the sequestration chamber 55could be formed of flexible tubing or other elastomeric materials. Thesequestration chamber 55 further includes an air permeable blood barrier20 that allows air to exit the sequestration chamber 55. As used hereinthe term “air permeable blood barrier” means an air permeable butsubstantially blood impermeable substance, material, or structure.Examples may include hydrophobic membranes and coatings, a hydrophilicmembrane or coating combined with a hydrophobic membrane or coating,mesh, a filter, a mechanical valve, antimicrobial material, or any othermeans of allowing air to be displaced from the sequestration chamber 55as it is filled with blood. In various exemplary embodiments, an airpermeable blood barrier may be formed by one or more materials thatallow air to pass through until contacted by a liquid, such materialthen becomes completely or partially sealed to prevent or inhibit thepassage of air and/or liquid. In other words, prior to contact withliquid, the material forms a barrier that is air permeable. Aftercontact with a liquid, the material substantially or completely preventsthe further passage of air and/or liquid.

The orifice or channel 45 can be any desired length, cross-sectionalshape or size, and/or can be formed to depart from the low volumechamber 30 at any desired angle or orientation. The orifice or channel45 may also include a one-way flap or valve 60 that maintains an initialaliquot of blood sample within the sequestration chamber 55. In somespecific implementations, the orifice or channel 45 can include a “duckbill” or flapper valve 60, or the like, for one-way flow of blood fromlow volume chamber 30 to the sequestration chamber 55. The air permeableblood barrier 20 can also be constructed of a material that allows airto exit but then seals upon contact with blood, thereby not allowingexternal air to enter sequestration chamber 55. This sealing wouldeliminate the need for a valve.

Valve 60 can be any type of valve or closing mechanism. Chamber 30 isdesigned to hold virtually no residual blood, and can be designed to beadapted to hold or allow pass-through of a particular volume or rate ofblood into sequestration chamber 55. Likewise, sequestration chamber 55may also include any type of coating, such as an anti-microbial coating,or a coating that aids identification and/or diagnosis of components ofthe first, sequestered blood draw.

Housing 50 and 40 can be formed of any suitable material, includingplastic, such as acrylonitrile butadiene styrene (ABS) or otherthermoplastic or polymeric material, rubber, steel, or aluminum. The airpermeable blood barrier 20 can include a color-providing substance, orother signaling mechanism, that is activated upon contact with bloodfrom the initial blood draw, or when air displacement is stopped, or anycombination of events with blood in the sequestration chamber 55. Theair permeable barrier may also include an outer layer such as ahydrophobic membrane or cover that inhibits or prevents the inadvertentor premature sealing of the filter by an external fluid source, splashetc. Sequestration chamber 55 can also be translucent or clear to enablea user to visually confirm the chamber is filled.

FIG. 2 illustrates a blood sample optimization system in accordance withsome alternative implementations. In the implementation shown in FIG. 2,a sequestration chamber 55, or waste chamber, surrounds the patientneedle 1, with an open-ended cuff or housing connected with the wastechamber and encircling the sample needle housing base and housing. Thepatient needle 1 and sample needle 5 are connected together by a boot56, which forms a continuous blood draw channel therethrough. The boot56 includes a single orifice or channel leading from the blood drawchannel into sequestration chamber 55. The device can include more thanone single orifice or channel, in other implementations. Each orifice orchannel can include a one-way valve, and can be sized and adapted forpredetermined amount of blood flow.

The sequestration chamber 55 includes an air permeable blood barrier.The filter can further include a sensor or indicator to sense and/orindicate, respectively, when a predetermined volume of blood has beencollected in the sequestration chamber 55. That indication will alert auser to attach an evacuated blood collection tube or bottle, such as aVacutainer™ to the sample needle 5. The housing for the sequestrationchamber 55 can be any size or shape, and can include any type ofmaterial to define an interior space or volume therein. The interiorspace is initially filled only with air, but can also be coated with anagent or substance, such as a decontaminate, solidifying agent, or thelike. Once evacuated blood collection tube is attached to the sampleneedle 5, blood will flow automatically into the patient needle 1,through the blood draw channel and sample needle 5, and into the bottle.The sample needle 5 is covered by a resealable boot, coating or membranethat seals the sample needle when a blood collection bottle is notattached thereon or thereto.

FIG. 3 illustrates a blood sample optimization system in accordance withsome alternative implementations. In the implementation shown, a sampleneedle 5 is surrounded by a resealable boot or membrane, and is furtherconnected with a patient needle 1. A blood flow channel is formedthrough the sample needle and the patient needle. The connection betweenthe sample needle and patient needle includes a “T” or “Y” connector102, which includes a channel, port or aperture leading out from themain blood flow channel to a sequestration chamber 104.

The T or Y connector 102 may include a flap or one-way valve, and havean opening that is sized and adapted for a predetermined rate of flow ofblood. The sequestration chamber 104 can be formed from tubing, or beformed by a solid housing, and is initially filled with air. Thesequestration chamber 104 will receive blood that flows out of a patientautomatically, i.e. under pressure from the patient's own bloodpressure. The sequestration chamber 104 includes an air permeable bloodbarrier 106, preferably at the distal end of tubing that forms thesequestration chamber 104, and which is connected at the proximal end tothe T or Y connector 102. The T or Y connector 102 can branch off at anydesired angle for most efficient blood flow, and can be formed so as tominimize an interface between the aperture and channel and the mainblood flow channel, so as to minimize or eliminate mixing of the initialaliquot of blood with main blood draw samples.

In some alternative implementations, the sample needle may be affixed toa tubing of any length, as shown in FIG. 4, connecting at its oppositeend to the T or Y connector 102. The sequestration chamber 104 can beany shape or volume so long as it will contain a predetermined amount ofblood sample in the initial aliquot. The T or Y connector 102 may alsoinclude an opening or channel that is parallel to the main blood flowchannel. The air permeable blood barrier may further include anindicator 107 or other mechanism to indicate when a predetermined amountof blood has been collected in the sequestration chamber, or when airbeing expelled reaches a certain threshold, i.e. to zero. The tubing canalso include a clip 109 that can be used to pinch off and prevent fluidflow therethrough.

Once the air permeable blood barrier and primary chamber are sealed theinitial aliquot of blood is trapped in the sequestration chamber 104, anevacuated blood collection tube, such as a Vacutainer™ bottle may beattached to the sample needle 5 to obtain the sample. The bloodcollection tube can be removed, and the sample needle 5 will beresealed. Any number of follow-on blood collection tubes can then beattached for further blood draws or samples. Upon completion of allblood draws, the system can be discarded, with the initial aliquot ofblood remaining trapped in the sequestration chamber 104.

FIG. 5 illustrates a blood sample optimization system in accordance withsome alternative implementations. In the implementation shown, a sampleneedle 5 is connected with a patient needle by tubing. A “T” or “Y”connector 120 is added along the tubing at any desired location, andincludes an aperture, port or channel leading to a sequestration chamber204, substantially as described above.

FIG. 6 illustrates a blood sample optimization system in accordance withsome alternative implementations, in which a sequestration chamber 304,formed as a primary collection channel, receives an initial aliquot ofblood, and is provided adjacent to the blood sampling channel. Thesequestration chamber 304 can encircle the blood sampling channel, thepatient needle 1, and/or the sample needle 5. The primary collectionchannel can include a T or Y connector 120, or other type of aperture orchannel. The sequestration chamber 304 includes an air permeable bloodbarrier, which can also include an indicator of being contacted by afluid such as blood, as described above.

In some implementations, either the patient needle 1 or the sampleneedle 5, or both, can be replaced by a Luer lock male or femaleconnector. However, in various implementations, the connector at asample needle end of the blood sample optimization system is initiallysealed to permit the diversion of the initial aliquot of blood to thesequestration chamber, which is pressured at ambient air pressure andincludes the air outlet of the air permeable blood barrier. In this way,the system passively and automatically uses a patient's own bloodpressure to overcome the ambient air pressure of the sequestrationchamber to push out air through the air permeable blood barrier anddisplace air in the sequestration chamber with blood.

FIG. 7 is a flowchart of an exemplary method for optimizing the qualityof a blood culture. At 702, a clinician places a needle into a patient'svein. At 704, blood then flows into a sequestration chamber, pushing theair in the sequestration chamber out of the sequestration chamberthrough an air permeable blood barrier. In some implementations, thevolume of the sequestration chamber is less than 0.1 to more than 5cubic centimeters (cc's), or more. The sequestration chamber is sizedand adapted to collect a first portion of a blood sample, which is moreprone to contamination than secondary and other subsequent portion ofthe blood sample or subsequent draws. Since the sequestration chamberhas an air-permeable blood barrier through which air can be displaced byblood pushed from the patient's vein, such blood will naturally andautomatically flow into the sequestration chamber before it is drawninto or otherwise enters into a Vacutainer or other bottle for receivingand storing a blood sample.

When the sequestration chamber fills, the blood will gather at orotherwise make contact with the air permeable blood barrier, which willinhibit or prevent blood from passing therethrough. At 706, when theblood comes into contact with the entire internal surface area of theair permeable blood barrier, the air permeable blood barrier is thenclosed and air no longer flows out or in. At 708, the clinician may beprovided an indictor or can see the full chamber, to indicate theevacuated blood collection tube, such as a VacutainerTM can be attached.The indicator can include visibility into the primary chamber to seewhether it is full, the blood barrier changing color, for example, orother indicator. The fill time of the sequestration chamber may besubstantially instantaneous, so such indicator, if present, may be onlythat the sequestration chamber is filled.

Prior to an evacuated blood collection tube being attached,communication between the needle, sampling channel, and thesequestration chamber is restricted by the sealing of the sequestrationchamber blood barrier thereby not permitting air to reenter the systemthrough the sequestration. Sealing the communication path could also beaccomplished with a mechanical twist or other movement, a small orificeor tortuous pathway, eliminating the need for a separate valve ormechanical movement or operation by the clinician. At 710, once theevacuated blood collection tube is removed, the self-sealing membranecloses the sample needle, and at 712, additional subsequent evacuatedblood collection tubes may be attached. Once samples have been taken, at714 the device is removed from the patient and discarded.

FIGS. 8A-8E illustrate an exemplary blood sample optimization system 800for non-contaminated blood sampling, in accordance with someimplementations. The blood sample optimization system 800 includes aninlet port 802 that can be connected to tubing, a patient needle (orboth), or other vascular or venous access device, and a pathway splitter804 having a first outlet to a sequestration chamber tubing 806 and asecond outlet to sample collection tubing 808. One or both of thesequestration chamber tubing 806 and the sample collection tubing 808can be formed of tubing. In some implementations, the sequestrationchamber tubing 806 is sized so as to contain a particular volume ofinitial blood sample. The sample collection tubing 808 will receive ablood sample once the sequestration chamber tubing 806 is filled. Thesample collection tubing 808 can be connected to a VacutainerTM base orhousing 810, or other blood sample collection device.

The blood sequestration system 800 further includes a bloodsequestration device 812 which, as shown in more detail in FIGS. 8B-8D,includes a housing 818 that includes a sampling channel 820 defining apathway for the non-contaminated sample collection tubing 808 orconnected at either end to the non-contaminated sample collection tubing808. The sampling channel 820 can be curved through the housing 818 soas to better affix and stabilize the housing 818 at a location along thenon-contaminated sample collection tubing 808.

The blood sequestration device 812 further includes a sequestrationchamber 822 connected with the sequestration chamber tubing 806 or otherchamber. The sequestration chamber 822 terminates at an air permeableblood barrier 824. The air permeable blood barrier 824 can also includea coloring agent that turns a different color upon full contact withblood, as an indicator that the regular collection of blood samples(i.e. the non-contaminated blood samples) can be initiated. Otherindicators may be used, such as a small light, a sound generationmechanism, or the like. In some implementations, the air permeable bloodbarrier is positioned at a right angle from the direction ofsequestration chamber 822, but can be positioned at any distance ororientation in order to conserve space and materials used for thehousing 818. The housing 818 and its contents can be formed of any rigidor semi-rigid material or set of materials.

FIG. 9 illustrates a pathway splitter 900 for use in a bloodsequestrations system, such as those shown in FIGS. 8A-8E, for example.The pathway splitter 900 includes an inlet port 902, a main line outletport 904, and a sequestration channel outlet port 906. The inlet port902 can be connected to main tubing that is in turn connected to apatient needle system, or directly to a patient needle. The main lineoutlet port 904 can be connected to main line tubing to a blood samplingsystem, such as a vacutainer base or housing, or directly to such bloodsampling system. The sequestration channel outlet port 906 can beconnected to sequestration tubing for receiving and sequestering a firstsample of blood, up to a measured amount or predetermined threshold.Alternatively, the sequestration channel outlet port 906 can beconnected to a sequestration chamber. The sequestration channel outletport 906 is preferably 20-70 degrees angled from the main line outletport 904, which in turn is preferably in-line with the inlet port 902.Once the predetermined amount of initial blood sample is sequestered inthe sequestration tubing or chamber, in accordance with mechanisms andtechniques described herein, follow-on blood samples will flow into theinlet port 902 and directly out the main line outlet port 904, withoutimpedance.

FIGS. 10A-10D illustrate a blood sequestration device 1000 in accordancewith alternative implementations. The blood sequestration device 1000includes an inlet port 1002, a main outlet port 1004, and asequestration channel port 1006. The inlet port 1002 can be connected toa patient needle or related tubing. The main outlet port 1004 can beconnected to a blood sample collection device such as a Vacutainer,associated tubing, or a Luer activated valve, or the like. Thesequestration channel port 1006 splits off from the main outlet port1004 to a sequestration chamber 1008. In some implementations, thesequestration chamber 1008 is formed as a helical channel within ahousing or other container 1001.

The sequestration chamber 1008 is connected at the distal end to an airpermeable blood barrier 1010, substantially as described above. Air inthe sequestration chamber 1008 is displaced through the air permeableblood barrier 1010 by an initial aliquot of blood that is guided intothe sequestration channel port 1006. Once the sequestration chamber 1008is filled, further blood draws through the main outlet port 1004 can beaccomplished, where these samples will be non-contaminated.

FIGS. 11A-11E illustrate a blood sequestration device 1100 in accordancewith other alternative implementations. The blood sequestration device1100 includes an inlet port 1102, similar to the inlet ports describedabove, a main outlet port 1104, and a sequestration channel port 1106that splits off from the main outlet port 1104 and inlet port 1102. Thesequestration channel port is connected to a sequestration chamber 1108.In the implementation shown in FIGS. 11A-11E, the blood sequestrationdevice includes a base member 1101 having a channel therein, whichfunctions as the sequestration chamber 1108. The channel can be formedas a tortuous path through the base member 1101, which is in turn shapedand formed to rest on a limb of a patient.

A portion of the sequestration chamber 1108 can protrude from the basemember or near a top surface of the base member, just before exiting toan air permeable blood barrier 1110, to serve as a blood sequestrationindicator 1109. The indicator 1109 can be formed of a clear material, ora material that changes color when in contact with blood.

In some implementations, the blood sequestration device 1100 can includea blood sampling device 1120 such as a normally closed needle,Vacutainer™ shield or other collection device. The blood sampling device1120 can be manufactured and sold with the blood sequestration device1100 for efficiency and convenience, so that a first aliquot of bloodthat may be contaminated by a patient needle insertion process can besequestered. Thereafter, the blood sampling device 1120 can drawnon-contaminated blood samples to reduce the risk of false positivetesting and ensure a non-contaminated sample.

FIGS. 12A-12D illustrate a blood sample optimization system 1200 inaccordance with yet other alternative implementations. The system 1200includes a blood sequestration device 1202 for attaching to a bloodsampling device 1204, such as a Vacutainer™ or other collection andsampling device. The blood sequestration device 1202 is configured andarranged to receive, prior to a Vacutainer™ container or vial beingattached to a collection needle of the blood sampling device 1204, afirst aliquot or amount of blood, and sequester that first aliquot oramount in a sequestration channel of the blood sequestration device1202.

In some implementations, the blood sequestration device 1202 can includean inlet port 1212, a main outlet port, and a sequestration channelport. The inlet port 1212 can be connected to a patient needle orrelated tubing. The main outlet port 1214 can be connected to a normallyclosed needle or device to enable connection with an evacuated bloodcollection container or other collection device such as a Vacutainer™,associated tubing, luer connectors, syringe, a Luer activated valve, orthe like. The sequestration channel port splits off from the main outletport to a sequestration chamber 1218.

In some implementations, the sequestration chamber 1218 is formed as achannel within the body of a sequestration device 1202. Thesequestration chamber 1218 can be a winding channel, such as a U-shapedchannel, an S-shaped channel, a helical channel, or any other windingchannel. The sequestration device 1202 can include a housing or othercontaining body, and one or more channels formed therein. As shown inFIGS. 12A and 12B, the sequestration device 1202 includes a main body1206 and a cap 1208. The main body 1206 is formed with one or morecavities or channels, which are further formed with one or more arms1210 that extend from the cap 1208, and which abut the cavities orchannels in the main body 1206 to form the primary collection port andmain outlet port.

FIGS. 13A-13D illustrate a blood sample optimization system 1300 inaccordance with yet other alternative implementations. The system 1300includes a blood sequestration device 1302 for attaching to a bloodsampling device 1304, such as a Vacutainer or other bodily fluidcollection and sampling device. The blood sequestration device 1302 isconfigured and arranged to receive, prior to a Vacutainer container orvial being attached to a collection needle of the blood sampling device1304, a first aliquot or amount of blood, and to sequester that firstaliquot or amount of blood or other bodily fluid in a sequestrationchannel of the blood sequestration device 1302.

The blood sequestration device 1302 includes a housing 1301 having aninlet port 1314, a main outlet port 1312, and a sequestration channelport 1316. The inlet port 1314 can be connected to a patient needle orassociated tubing. The main outlet port 1312 can be connected to anormally closed needle or device to enable connection with an evacuatedblood collection container or other collection device such as aVacutainer™, associated tubing, luer connectors, syringe, a Lueractivated valve, or the like. The sequestration channel port 1316 splitsoff from the main inlet port 1314 to a sequestration chamber 1318.

In the implementation shown in FIGS. 13A-D, the sequestration chamber1318 is formed as a cavity or chamber within housing 1301 or formed bywalls that define housing 1301. The sequestration chamber 1318 can be awinding channel, such as a U-shaped channel, an S-shaped channel, ahelical channel, or any other winding channel, that is defined by thecooperation and connection of housing 1301 with cap 1307 which cap 1307can include a protrusion 1305 that provides one or more walls ordirectors for the winding channel in the sequestration chamber 1318. Theprotrusion 1305 from the cap 1307 can be straight or curved, and mayhave various channels, apertures or grooves embedded therein, and canextend from the cap 1307 any angle or orientation. When the cap 1307 isconnected with the housing 1301 to complete the formation of thesequestration chamber 1318, the protrusion 1305 forms at least part ofthe winding channel to sequester a first aliquot or amount of blood orother bodily fluid in a sequestration channel formed in thesequestration chamber 1318 and by the winding channel.

The sequestration chamber 1318 includes an air permeable blood barrier1310, substantially as described above. Air in the sequestration chamber1318 is displaced through the air permeable blood barrier 1310 by aninitial aliquot of blood that is provided into the sequestration chamber1318 by the blood pressure of the patient. Once the sequestrationchamber 1318 is filled and the air in the sequestration chamber 1318displaced, the blood pressure of the patient will be insufficient todrive or provide further blood into the blood sequestration device 1302,and in particular the outlet port 1312, until a force such as a vacuumor other pressure, such as provided by the blood sample collectiondevice like Vacutainer is provided to draw out a next aliquot or amountof blood or bodily fluid. Further blood draws through the main outletport 1312 can be accomplished, where these samples will benon-contaminated since any contaminants would be sequestered in thesequestration chamber 1318 with the first aliquot of blood.

FIGS. 14A-14E illustrate yet another implementation of a blood samplingsystem 1400 to sequester contaminates of an initial aliquot or sample toreduce false positives in blood cultures or tests performed on apatient's blood sample. The blood sampling system 1400 includes a bloodsequestration device 1401 that can be connected between a blood samplecollection device 1403 and a patient needle (not shown). The bloodsample collection device 1403 can be a Vacutainer or the like. The bloodsequestration device 1401 includes an inlet port 1402 that can beconnected with a patient needle that is inserted into a patient'svascular system for access to and withdrawing of a blood sample. Theinlet port 1402 may also be connected with tubing or other conduit thatis in turn connected with the patient needle.

The inlet port 1402 defines an opening into the blood sequestrationdevice 1401, which opening can be the same cross sectional dimensions astubing or other conduit connected with the patient needle or the patientneedle itself. For instance, the opening can be circular with a diameterof approximately 0.045 inches, but can have a diameter of between 0.01inches or less to 0.2 inches or more. The blood sequestration device1401 further includes an outlet port 1404, which defines an opening outof the blood sequestration device 1401 and to the blood samplecollection device 1403. The outlet port 1404 may also be connected withtubing or other conduit that is in turn connected with the bloodsequestration device 1403. The outlet port 1404 can further include aconnector device such as a threaded cap, a Luer connector (male orfemale), a non threaded interference or glue joint fitting forattachment of various devices including but not limited to tubing, orthe like.

The blood sequestration device 1401 further includes a sampling channel1406 between the inlet port 1402 and the outlet port 1404, and whichfunctions as a blood sample pathway once a first aliquot of blood hasbeen sequestered. The sampling channel 1406 can be any sized, shaped orconfigured channel, or conduit. In some implementations, the samplingchannel 1406 has a substantially similar cross sectional area as theopening of the inlet port 1402. In other implementations, the samplingchannel 1406 can gradually widen from the inlet port 1402 to the outletport 1404.

The blood sequestration device 1401 further includes a sequestrationchamber 1408 that is connected to and split off or diverted from thesampling channel 1406 at any point between the inlet port 1402 and theoutlet port 1404, but preferably from a proximal end of the samplingchannel 1406 near the inlet port 1402. The sequestration chamber 1408 isat first maintained at atmospheric pressure, and includes an air outlet1412 at or near a distal end of the sequestration chamber 1408 oppositethe diversion point from the sampling channel 1406. The air outlet 1412includes an air permeable blood barrier 1412. As shown in FIG. 14B, theair permeable blood barrier 1412 can be overlaid with a protective cover1416. The protective cover 1416 can be sized and configured to inhibit auser from touching the air permeable blood barrier 1412 with theirfinger or other external implement, while still allowing air to exit theair permeable blood barrier 1412 as the air is displaced from thesequestration chamber 1408 by blood being forced into the sequestrationchamber 1408 by a patient's own blood pressure. In addition theprotective cover 1416 can be constructed to inhibit or preventaccidental exposure of the air permeable blood barrier to environmentalfluids or splashes. This can be accomplished in a variety of mechanicalways including but not limited to the addition of a hydrophobic membraneto the protective cover.

As shown in FIGS. 14C and 14D, the sampling channel 1406 can becylindrical or frusto-conical in shape, going from a smaller diameter toa larger diameter, to minimize a potential to lyse red blood cells.Likewise, the sampling channel 1406 is formed with a minimal amount ofor no sharp turns or edges, which can also lyse red blood cells. Thesampling channel 1406 splits off to the sequestration chamber 1408 nearthe inlet port 1402 via a diversion pathway 1409. The diversion pathway1409 can have any cross-sectional shape or size, but is preferablysimilar to the cross-sectional shape of at least part of the inlet port1402.

In some implementations, the sampling channel 1406 and the sequestrationchamber 1408 are formed by grooves, channels, locks or other pathwaysformed in housing 1414. The housing 1414 can be made of plastic, metalor other rigid or semi-rigid material. The housing 1414 can have abottom member that sealably mates with a top member. One or both of thebottom member and the top member can include the sampling channel 1406and the sequestration chamber 1408, as well as the diversion pathway1409, the inlet port 1402, and the outlet port 1404. In some otherimplementations, one or more of the diversion pathway 1409, the inletport 1402, and/or the outlet port 1404 can be at least partially formedby a cap member that is connected to either end of the housing 1414. Insome implementations, the top member and the bottom member, as well asthe cap member(s), can be coupled together by laser welding, heatsealing, gluing, snapping, screwing, bolting, or the like. In otherimplementations, some or all of the interior surface of the diversionpathway 1409 and/or sequestration chamber 1408 can be coated or loadedwith an agent or substance, such as a decontaminate, solidifying agent,or the like. For instance, a solidifying agent can be provided at thediversion pathway 1409 such that when the sequestration chamber 1408 isfilled and the initial aliquot of blood backs up to the diversionpathway 1409, that last amount of sequestered blood could solidify,creating a barrier between the sequestration chamber 1408 and thesampling channel 1406.

FIGS. 15A-15G illustrate a blood sequestration device 1500. The bloodsequestration device 1500 can be connected to a normally closed needleor device to enable connection with an evacuated blood collectioncontainer or other collection device such as a Vacutainer™, associatedtubing, luer connectors, syringe, a Luer activated valve, or the like.

The blood sequestration device 1500 includes an inlet port 1502 that canbe connected with a patient needle that is inserted into a patient'svascular system for access to and withdrawing of a blood sample. Theinlet port 1502 may also be connected with tubing or other conduit thatis in turn connected with the patient needle. The inlet port 1502defines an opening into the blood sequestration device 1500, whichopening may be the same cross sectional dimensions as tubing or otherconduit connected with the patient needle or the patient needle itself.For instance, the opening can be circular with a diameter ofapproximately 0.045 inches, but can have a diameter of between 0.01inches or less to 0.2 inches or more.

The inlet port 1502 can also include a sealing or fluid-tight connectoror connection, such as threading or Luer fitting, or the like. In someimplementations, tubing or other conduit associated with the patientneedle can be integral with the inlet port 1502, such as by co-molding,gluing, laser weld, or thermally bonding the parts together. In thismanner, the blood sequestration device 1500 can be fabricated and soldwith the patient needle as a single unit, eliminating the need forconnecting the patient needle to the blood sequestration device 1500 atthe time of blood draw or sampling.

The blood sequestration device 1500 further includes an outlet port1504, which defines an opening out of the blood sequestration device1500 and to the blood sample collection device. The outlet port 1504 mayalso be connected with tubing or other conduit that is in turn connectedwith the blood sequestration device, and may also include a sealing orfluid-tight connector or connection, such as threading or Luer fitting,or the like. Accordingly, as discussed above, the blood sequestrationdevice 1500 can be fabricated and sold with the patient needle and/ortubing and the blood sample collection device as a single unit,eliminating the need for connecting the patient needle and the bloodsample collection device to the blood sequestration device 1500 at thetime of blood draw or sampling.

The blood sequestration device 1500 further includes a sampling channel1506 between the inlet port 1502 and the outlet port 1504, and whichfunctions as a blood sample pathway once a first aliquot of blood hasbeen sequestered. The sampling channel 1506 can be any sized, shaped orconfigured channel or conduit. In some implementations, the samplingchannel 1506 has a substantially similar cross sectional area as theopening of the inlet port 1502. In other implementations, the samplingchannel 1506 can gradually widen from the inlet port 1502 to the outletport 1504.

The blood sequestration device 1500 further includes a sequestrationchamber 1508 that is connected to and split off or diverted from thesampling channel 1506 at any point between the inlet port 1502 and theoutlet port 1504, but preferably from a proximal end of the samplingchannel 1506 near the inlet port 1502. In some implementations, thediversion includes a Y-shaped junction. The sequestration chamber 1508is preferably maintained at atmospheric pressure, and includes a vent1510 at or near a distal end of the sequestration chamber 1508. The vent1510 includes an air permeable blood barrier 1512. FIG. 15C illustratesthe blood sequestration device 1500 with the sequestration chamber 1508filled with a first aliquot or sample of blood from the patient.

The air permeable blood barrier 1512 can be covered with a protectivecover 1516. The protective cover 1516 can be sized and configured toinhibit a user from touching the air permeable blood barrier 1512 withtheir finger or other external implement, while still allowing air toexit the air permeable blood barrier 1512 as the air is displaced fromthe sequestration chamber 1508 by blood being forced into thesequestration chamber 1508 by a patient's own blood pressure. Theprotective cover 1516 can be constructed to inhibit or preventaccidental exposure of the filter to environmental fluids or splashes.This can be accomplished in a variety of mechanical ways including butnot limited to the addition of a hydrophobic membrane to the protectivecover.

FIG. 15B is a perspective view of the blood sequestration device 1500from the outlet port 1504 and top side of a housing 1501 of the bloodsequestration device 1500 that includes the vent 1510, and illustratingan initial aliquot of blood filling sequestration chamber 1508 while thesampling channel 1506 is empty, before a sample collection device isactivated. FIG. 15G is a perspective view of the blood sequestrationdevice 1500 from the outlet port 1504 and bottom side of the housing1501 of the blood sequestration device 1500, and illustrating theinitial aliquot of blood filling sequestration chamber 1508 while thesampling channel 1506 is empty, before the sample collection device isactivated. FIG. 15C is another perspective view of the bloodsequestration device 1500 from the inlet port 1502 and top side of ahousing 1501 of the blood sequestration device 1500 that includes thevent 1510, and illustrating blood now being drawn through samplingchannel 1506 while the sequestered blood remains substantially in thesequestration chamber 1508.

FIG. 15D is a cross section of the blood sequestration device 1500 inaccordance with some implementations, showing the housing 1501 thatdefines the sampling channel 1506 and the sequestration chamber 1508.FIGS. 15E and 15F illustrate various form factors of a housing for ablood sequestration device, in accordance with one or moreimplementations described herein.

The sequestration chamber 1508 can have a larger cross-sectional areathan the sampling channel 1506, and the cross-sectional area and lengthcan be configured for a predetermined or specific volume of blood to besequestered or locked. The sampling channel 1506 can be sized to becompatible with tubing for either or both of the patient needle tubingor the blood collection device tubing.

The housing 1501 can be formed of multiple parts or a single, unitarypart. In some implementations, and as illustrated in FIG. 15D, thehousing 1501 includes a top member 1520 and a bottom member 1522 thatare mated together, one or both of which having grooves, channels,locks, conduits or other pathways pre-formed therein, such as by aninjection molding process or by etching, cutting, drilling, etc. The topmember 1520 can be connected with the bottom member 1522 by any matingor connection mechanism, such as by laser welding, thermal bonding,ultrasonic welding, gluing, using screws, rivets, bolts, or the like, orby other mating mechanisms such as latches, grooves, tongues, pins,flanges, or the like.

In some implementations, such as shown in FIG. 15D, the top member 1520can include the grooves, channels, locks, conduits or other pathways,while the bottom member 1522 can include a protrusion 1524 that is sizedand adapted to fit into at least one of the grooves, channels, locks orother pathways of the top member 1520. The protrusion 1524 can provide asurface feature, such as a partial groove or channel, for instance, tocomplete the formation of either the sampling channel 1506 and/or thesequestration chamber 1508. In some implementations, the protrusion 1524can be formed with one or more angled sides or surfaces for a tighterfit within the corresponding groove, channel, lock or other pathway. Inyet other implementations, both the top member 1520 and the bottommember can include grooves, channels, locks or other pathways, as wellas one or more protrusions 1524.

In some implementations, the sampling channel 1506 and the sequestrationchamber 1508 are formed by grooves, channels, locks or other pathwaysformed in housing 1501. The housing 1501 can be made of any suitablematerial, including rubber, plastic, metal or other material. Thehousing 1501 can be formed of a clear or translucent material, or of anopaque or non-translucent material. In other implementations, thehousing 1501 can be mostly opaque or non-translucent, while the housingsurface directly adjacent to the sampling channel 1506 and/or thesequestration chamber 1508 is clear or translucent, giving apractitioner a visual cue or sign that the sequestration chamber 1508 isfirst filled to the extent necessary or desired, and/or then a visualcue or sign that the sequestered blood remains sequestered while a cleansample of blood is drawn through the sampling channel 1506. Other visualcues or signs of the sequestration can include, without limitation: theair permeable blood barrier 1512 turning a different color upon contact,saturation, or partial saturation with blood; a color-coded tab orindicator at any point along or adjacent to the sequestration chamber;an audible signal; a vibratory signal; or other signal.

After a venipuncture by a patient needle of a patient (not shown), whichcould gather a number of pathogens from the patient's skin, a firstamount of the patient's blood with those pathogens will make its wayinto the inlet port 1502 blood sequestration device 1500 and flow intothe sequestration chamber 1508 by following the path of leastresistance, as the patient's own blood pressure overcomes theatmospheric pressure in the sequestration chamber 1508 to displace airtherein through the air permeable blood barrier 1512. The patient'sblood pressure will not be sufficient to overcome the air pressure thatbuilds up in the sealed sampling channel 1506. Eventually, thesequestration chamber 1508, which has a predetermined volume, is filledwith blood that displaces air through the air permeable blood barrier1512. Once the blood hits the air permeable blood barrier, the bloodinteracts with the air permeable blood barrier 1512 material tocompletely or partially seal the vent 1510. A signal or indication maybe provided that the practitioner can now utilize the Vacutainer capsuleor other blood sample collection device to acquire a next amount of thepatient's blood for sampling. The blood in the sequestration chamber1508 is now effectively sequestered in the sequestration chamber.

Upon filling the blood sequestration pathway 1508 but prior to use ofthe Vacutainer or other blood sample collection device, the patient'sblood pressure may drive compression of the air in the sampling channel1506, possibly resulting in a small amount of blood moving past thediversion point to the sequestration chamber 1508 and into the samplingchannel 1506, queuing up the uncontaminated blood to be drawn throughthe sampling channel 1506.

In some instances, as shown in FIG. 15H, an inlet port 1532 can includea male luer connector for connecting to a removable patient needle, andan outlet port 11534 can include a female luer connector for connectingwith a syringe. This implementation of the inlet port and outlet portcan be used with any device described herein, for avoiding a propensityof a Vacutainer-type device collapsing a patient's vein. In thisimplementation, a clinician can use the syringe in a modulated fashionto obtain a blood sample. In operation, the syringe is attached to theoutlet port 1004, and the needle is attached to the inlet port 1002. Avenipuncture is performed with the needle, and without the clinicianpulling on the syringe. An initial aliquot of blood fills asequestration chamber, and then the syringe can be used to draw a sampleof blood through the collection channel, bypassing the sequestered bloodin the sequestration chamber.

FIGS. 16-19 illustrate yet another implementation of a bloodsequestration device. FIGS. 16A-16D illustrate a blood sequestrationdevice 1600 that can be connected between a blood sample collectiondevice, such as an evacuated blood collection container like aVacutainer™ (not shown), and a patient needle (not shown) and/orassociated tubing. FIG. 17 illustrates a bottom member of the bloodsequestration device, and FIG. 18 illustrates a top member of the bloodsequestration device, which top member and bottom member can be matedtogether to form an inlet port, and outlet port, a sequestration chamberand a sampling channel, as explained more fully below. FIGS. 19A and Bshow the top member and bottom member mated together. It should beunderstood that FIGS. 16-19 illustrate one exemplary manner ofconstructing a blood sequestration device as described herein, and otherforms of construction are possible.

Referring to FIGS. 16A-D, the blood sequestration device 1600 includesan inlet port 1602 that can be connected with a patient needle that isinserted into a patient's vascular system for access to and withdrawingof a blood sample. The inlet port 1602 may also be connected with tubingor other conduit that is in turn connected with the patient needle. Theinlet port 1602 defines an opening into the blood sequestration device1600, which opening can be the same cross sectional dimensions as tubingor other conduit connected with the patient needle or the patient needleitself. For instance, the opening can be circular with a diameter ofapproximately 0.045 inches, but can have a diameter of between 0.01inches or less to 0.2 inches or more.

The inlet port 1602 can also include a sealing or fluid-tight connectoror connection, such as threading or Luer fitting, or the like. In someimplementations, tubing or other conduit associated with the patientneedle can be integral with the inlet port 1602, such as by co-molding,gluing, laser weld, or thermally bonding the parts together. In thismanner, the blood sequestration device 1600 can be fabricated and soldwith the patient needle and/or tubing as a single unit, eliminating theneed for connecting the patient needle to the blood sequestration device1600 at the time of blood draw or sampling.

The blood sequestration device 1600 further includes an outlet port1604, which defines an opening out of the blood sequestration device1600 and to the blood sample collection device. The outlet port 1604 mayalso be connected with tubing or other conduit that is in turn connectedwith the blood sequestration device, and may also include a sealing orfluid-tight connector or connection, such as threading or Luer fitting,or the like. Accordingly, as discussed above, the blood sequestrationdevice 1600 can be fabricated and sold with the patient needle and/ortubing and the blood sample collection device as a single unit,eliminating the need for connecting the patient needle and the bloodsample collection device to the blood sequestration device 1600 at thetime of blood draw or sampling.

The blood sequestration device 1600 further includes a sampling channel1606 between the inlet port 1602 and the outlet port 1604, and asequestration chamber 1608 that is connected to and split off ordiverted from the sampling channel 1606 at any point between the inletport 1602 and the outlet port 1604. The sampling channel 1606 functionsas a blood sampling pathway once a first aliquot of blood has beensequestered in the sequestration chamber 1608. The sampling channel 1606can be any sized, shaped or configured channel, or conduit. In someimplementations, the sampling channel 1606 has a substantially similarcross sectional area as the opening of the inlet port 1602. In otherimplementations, the sampling channel 1606 can gradually widen from theinlet port 1602 to the outlet port 1604. The sequestration chamber 1608may have a larger cross section to form a big reservoir toward thesequestration channel path so that the blood will want to enter thereservoir first versus entering a smaller diameter on the samplingchannel 1606, as is shown more fully in FIGS. 17 and 19.

In some exemplary implementations, the diversion between the samplingchannel 1606 and the sequestration chamber 1608 is by diverter junction1607. Diverter junction 1607 may be a substantially Y-shaped, T-shaped,or U-shaped. In some preferred exemplary implementations, and as shownin FIG. 17A-17B, the diverter junction 1607 is configured such that theflow out of the inlet port 1602 is preferentially directed toward thesequestration chamber 1608. The sequestration chamber 1608 may alsoinclude or form a curve or ramp to direct the initial blood flow towardand into the sequestration chamber 1608.

The sequestration chamber 1608 is preferably maintained at atmosphericpressure, and includes a vent 1610 at or near a distal end of thesequestration chamber 1608. The vent 1610 may include an air permeableblood barrier 1612 as described above.

The blood sequestration device 1600 can include a housing 1601 that canbe formed of multiple parts or a single, unitary part. In someimplementations, and as illustrated in FIGS. 17A-17E and FIGS. 18A-18F,the housing 1601 includes a top member 1620 and a bottom member 1622that are mated together. The blood sequestration device 1600 can alsoinclude a gasket or other sealing member (not shown) so that when thetop member 1620 is mechanically attached with the bottom member 1622,the interface between the two is sealed by the gasket or sealing member.The FIGS. 17A-17E illustrate a bottom member 1622 of a housing for ablood sequestration device 1600. The bottom member 1622 can includegrooves, channels, locks, conduits or other pathways pre-formed therein,such as by an injection molding process or by etching, cutting,drilling, etc., to form the sampling channel 1606, the sequestrationchamber 1608, and diverter junction 1607.

The sequestration chamber 1608 may have a larger cross section than thesampling channel 1606 so that the blood will preferentially move intothe sequestration chamber first versus entering a smaller diameter onthe sampling channel 1606.

FIGS. 18A-18F illustrate the top member 1620, which can be connectedwith the bottom member 1622 by any mating or connection mechanism, suchas by laser welding, thermal bonding, gluing, using screws, rivets,bolts, or the like, or by other mating mechanisms such as latches,grooves, tongues, pins, flanges, or the like. The top member 1620 caninclude some or all of the grooves, channels, locks, conduits or otherpathways to form the sampling channel 1606, the sequestration chamber1608, and the diverter junction 1607. In yet other implementations, boththe top member 1620 and the bottom member 1622 can include the grooves,channels, locks or other pathways.

In some implementations, the sampling channel 1606 and the sequestrationchamber 1608 are formed by grooves, channels, locks or other pathwaysformed in housing 1601. The housing 1601 can be made of rubber, plastic,metal or any other suitable material. The housing 1601 can be formed ofa clear or translucent material, or of an opaque or non-translucentmaterial. In other implementations, the housing 1601 can be mostlyopaque or non-translucent, while the housing surface directly adjacentto the sampling channel 1606 and/or the sequestration chamber 1608 maybe clear or translucent, giving a practitioner a visual cue or sign thatthe sequestration chamber 1608 is first filled to the extent necessaryor desired, and/or then a visual cue or sign that the sequestered bloodremains sequestered while a clean sample of blood is drawn through thesampling channel 1606. Other visual cues or signs of the sequestrationcan include, without limitation: the air permeable blood barrier 1612turning a different color upon contact, saturation, or partialsaturation with blood; a color-coded tab or indicator at any point alongor adjacent to the sequestration chamber; an audible signal; a vibratorysignal; or other signal.

As shown in FIGS. 18A-18F, the air permeable blood barrier 1612 can becovered with, or surrounded by, a protective member 1616. The protectivemember 1616 can be sized and configured to inhibit a user from touchingthe air permeable blood barrier 1612 with their finger or other externalimplement, while still allowing air to exit the air permeable bloodbarrier 1612 as the air is displaced from the sequestration chamber1608. In some implementations, the protective member 1616 includes aprotrusion that extends up from a top surface of the top member 1620 andaround the air permeable blood barrier 1612. The protective member 1616can be constructed to inhibit or prevent accidental exposure of thefilter to environmental fluids or splashes. This can be accomplished ina variety of mechanical ways including but not limited to the additionof a hydrophobic membrane to the protective cover.

In use, the blood sequestration device 1600 includes a sampling channel1606 and a sequestration chamber 1608. Both pathways are initiallyair-filled at atmospheric pressure, but the sampling channel 1606 isdirected to an outlet port 1604 that will be initially sealed by aVacutainer or other such sealed blood sampling device, and thesequestration chamber 1608 terminates at a vent 1610 to atmosphere thatincludes an air permeable blood barrier 1612.

After a venipuncture by a patient needle of a patient (not shown), whichcould gather a number of pathogens from the patient's skin, a firstamount of the patient's blood with those pathogens will pass throughinlet port 1602 of blood sequestration device 1600. This initial volumeof potentially contaminated blood will preferentially flow into thesequestration chamber 1608 by finding the path of least resistance. Thepatient's own blood pressure overcomes the atmospheric pressure in thevented sequestration chamber 1608 to displace air therein through theair permeable blood barrier 1612, but is not sufficient to overcome theair pressure that builds up in the sealed sampling channel 1606. Invarious exemplary embodiments, the sequestration chamber 1608 andsampling channel 1606 can be configured such that the force generated bythe patient's blood pressure is sufficient to overcome any effect ofgravity, regardless of the blood sequestration device's orientation.

Eventually, the sequestration chamber 1608 fills with blood thatdisplaces air through the air permeable blood barrier 1612. Once theblood contacts the air permeable blood barrier, the blood interacts withthe air permeable blood barrier 1612 material to completely or partiallyseal the vent 1610. A signal or indication may be provided that thepractitioner can now utilize the Vacutainer or other blood samplingdevice.

Upon filling the blood sequestration pathway 1608 but prior to use ofthe Vacutainer or other blood sample collection device, the patient'sblood pressure may drive compression of the air in the sampling channel1606, possibly resulting in a small amount of blood moving past thediversion point into the sampling channel 1606, queuing up theuncontaminated blood to be drawn through the sampling channel 1606.

FIG. 19A is a side view, and FIG. 19B is a cross-sectional view, of theblood sequestration device 1600, illustrating the top member 1620 matedwith the bottom member 1622.

FIG. 20 shows a blood sample optimization system 2000 that includes apatient needle 2002 for vascular access to a patient's bloodstream, ablood sample collection device 2004 to facilitate the collecting of oneor more blood samples, and a conduit 2006 providing a fluid connectionbetween the patient needle 2002 and the blood sample collection device2004. In some implementations, the blood sample collection device 2004includes a protective shield that includes a sealed collection needle onwhich a sealed vacuum-loaded container is placed, which, once pierced bythe collection needle, draws in a blood sample under vacuum pressure orforce through the conduit 2006 from the patient needle 2002.

The blood sample optimization system 2000 further includes a bloodsequestration device 2008, located at any point on the conduit 2006between the patient needle 2002 and the blood sample collection device2004 as described herein.

FIG. 21 illustrates a non-vented blood sequestration device 2100 using awicking material chamber. The blood sequestration device 2100 includes ahousing 2101 that has a sampling channel 2104 that is at least partiallysurrounded or abutted by a sequestration chamber 2102 that is filledwith a wicking material. An initial aliquot of blood is drawn in fromthe patient needle into the sampling channel 2104 where it isimmediately wicked into the wicking material of the sequestrationchamber 2102. The wicking material and/or sequestration chamber 2102 issized and adapted to receive and hold a predetermined amount of blood,such that follow-on or later blood draws pass by the wicking materialand flow straight through the sampling channel 2104 to a sampling devicesuch as a Vacutainer. The wicking material can include a substance suchas a solidifier, a decontaminate, or other additive.

As described herein, an air permeable blood barrier may be created usinga wide variety of different structures and materials. As shown in FIGS.22A and B, an air permeable blood barrier 2202 of a blood sequestrationdevice 2200 can include a polymer bead matrix 2204, in which at leastsome beads are treated to make them hydrophilic. The air permeable bloodbarrier 2202 further includes a self-sealing material 2206, such ascarboxymethyl cellulose (CMC) or cellulose gum, or other sealingmaterial. The air permeable blood barrier 2202 can further include voids2208 that permit air flow before contact or during partial contact witha fluid such as blood. As shown in FIG. 22B, contact with a fluid causesthe self-sealing material 2206 to swell and close off the voids 2208,occluding air flow through the voids 2208 and creating a complete orpartial seal.

FIGS. 23A and B illustrate yet another implementation of a bloodsequestration device 2300, having an inlet port 2302 to connect with apatient needle, an outlet port 2304 to connect with a blood samplecollection device, a sequestration chamber 2306, and a sampling channel2308 that bypasses the sequestration chamber 2306 once the sequestrationchamber is filled to an initial aliquot of potentially contaminatedblood to be sequestered. The sequestration chamber 2306 includes ahydrophobic plug 2312 at a distal end of the sequestration chamber 2306that is farthest from the inlet port 2302. A vacuum or other drawingforce applied from the outlet port 2304, such as from a Vacutainer orthe like, draws in blood into the inlet port 2302 and directly into thesequestration chamber 2306, where the initial aliquot of blood willcontact the hydrophobic plug 2312 and cause the initial aliquot of bloodto back up into the sequestration chamber 2306 and be sequestered there.A small amount of blood may make its way into the sampling channel 2308,which is initially closed off by valve 2308. Upon release of the valve2308, and under further force of the vacuum or other force, follow-onamounts of blood will flow into inlet port 2302, bypass thesequestration chamber 2306, and flow into and through sampling channel2308 toward the outlet port 2304 and to the collection device.

The sampling channel 2308 can have any suitable geometry and can beformed of plastic tubing or any other suitable material. Valve 2308 canbe a clip or other enclosing device to pinch, shunt, bend or otherwiseclose off the sampling channel 2308 before the initial aliquot of bloodis sequestered in the sequestration chamber 2306. For instance, valve2308 can also be formed as a flap, door or closable window or barrierwithin the sampling channel 2308.

FIGS. 23C-23E illustrate an alternative implementation of the bloodsequestration device 2300′, in which a sequestration chamber 2320branches off from a main collection channel 2322 between an inlet port2316 to connect with a patient needle and an outlet port 2318 to connectwith a blood sample collection device, such as a Vacutainer, a syringe,or the like. The sequestration chamber 2320 includes an air-permeable,blood impermeable blood barrier 2324, such as a hydrophobic plug ofmaterial, or a filter formed of one or more layers, for example. A valve2324 closes off and opens the collection channel 2322, and the device2300′ can be used similarly as described above.

FIG. 24A-24D illustrate a blood sample optimization system 2400 thatincludes a patient needle 2402 for vascular access to a patient'sbloodstream, a blood sample collection device 2404 to facilitate thecollecting of one or more blood samples for blood testing or bloodcultures, and a conduit 2406 providing a fluid connection between thepatient needle 2402 and the blood sample collection device 2404. In someimplementations, the blood sample collection device 2404 includes aprotective shield that includes a sealed collection needle on which asealed vacuum-loaded container is placed, which, once pierced by thecollection needle, draws in a blood sample under vacuum pressure orforce through the conduit 2006 from the patient needle 2402.

The blood sample optimization system 2400 further includes a bloodsequestration device 2408, located at any point on the conduit 2406between the patient needle 2402 and the blood sample collection device2404. The location of the blood sequestration device 2408 can be basedon a length of the conduit between the blood sequestration device 2408and the patient needle 2402, and the associated volume that lengthprovides.

The blood sequestration device 2408 includes an inlet port 2412 forbeing connected to the conduit 2406 toward the patient needle 2402, andan outlet port 2414 for being connected to the conduit 2406 toward theblood sample collection device 2404, and a housing 2416. The housing2416 can be any shape, although it is shown in FIGS. 24A-D as beingsubstantially cylindrical, and includes the inlet port 2412 and outletport 2414, which can be located anywhere on the housing although shownas being located on opposite ends of the housing 2416.

The blood sequestration device 2408 further includes a bloodsequestration chamber 2418 connected with the inlet port 2412. The bloodsequestration chamber 2418 is defined by an inner chamber housing 2419that is movable from a first position to receive and sequester a firstaliquot of blood, to a second position to expose one or more apertures2424 at a proximal end of the inner chamber housing 2419 to allow bloodto bypass and/or flow around the inner chamber housing 2419 and througha blood sample channel 2422 defined by the outer surface of the innerchamber housing 2419 and the inner surface of the housing 2416. Theblood sequestration chamber 2418 includes an air permeable blood barrier2420 at a distal end of the blood sequestration chamber 2418.

In operation, the inner chamber housing 2419 is in the first positiontoward the inlet port 2412, such that the one or more apertures 2424 areclosed, and the blood sequestration chamber 2418 is in a direct pathfrom the patient needle. Upon venipuncture of a patient, and drawing ofblood by way of a syringe or Vacutainer, or other blood collectiondevice 2404, the initial aliquot of blood flows into the bloodsequestration chamber 2418. As the initial aliquot of blood flows intothe blood sequestration chamber, it displaces air therein and eventuallythe blood contacts the blood barrier 2420, forcing the inner chamberhousing to the second position. The inner chamber housing 2419 and/orhousing 2416 can include a locking mechanism of one or more small tabs,grooves, detents, bumps, ridges, or the like, to maintain the innerchamber housing 2419 in the first position until the blood sequestrationchamber 2418 is filled, providing force to overcome the lockingmechanism to enable movement of the inner chamber housing 2419 to thesecond position. Once in the second position, the initial aliquot ofblood is sequestered in the blood sequestration chamber 2418 and the oneor more apertures 2424 are opened to create a pathway from the inletport 2412 to the blood sampling channel 2422, bypassing and/or flowingaround the blood sequestration chamber 2418.

As described above, the housing 2416 and/or inner chamber housing 2419can be formed as cylindrical and concentric, but can be any shape, suchas squared, rectangular, elliptical, oval, or other cross-sectionalshape. The outer surface of the distal end of the inner chamber housing2419 can have one or more outwardly projecting tangs 2421 with gapstherebetween. The tangs 2421 contact the inner surface of the housing2416 to help define the blood sampling channel 2422 therebetween, and tohelp stop the inner chamber housing 2419 in the second position. Thegaps between the tangs 2421 enable blood to flow through the bloodsampling channel 2422 and to the outlet port 2414. When the innerchamber housing 2419 is in the second position and the bloodsequestration chamber 2418 is filled with the first aliquot of blood,further blood samples will automatically flow through the inlet port2412, through the one or more apertures 2424, through the blood samplingchannel 2422, through the gaps between the tangs 2421, and ultimatelythrough the outlet port 2414 to be collected by a blood sampling device2404.

FIGS. 25A-D show a blood optimization system 2500 and bloodsequestration device 2502, formed substantially as described in FIGS.15, 16, 17, 18 and 19, but being formed to inhibit a user or otherobject from touching or blocking an air venting mechanism from a bloodsequestration chamber 2520. Air initially in the blood sequestrationchamber 2520 is displaced by an initial aliquot of blood uponvenipuncture, where a patient's blood pressure overcomes the ambient airpressure in the blood sequestration chamber 2520. The air ventingmechanism includes an air permeable blood barrier 2506, such as a porousmaterial or set of materials that allows air to escape but blocks bloodfrom leaving the blood sequestration chamber 2520.

The air venting mechanism includes an inner wall 2516 that at leastpartially circumscribes or surrounds the air permeable blood barrier2506, and an outer wall 2504 spaced apart from the inner wall 2516. Theouter wall 2504 can have one or more air vents 2514 formed therein. Theouter wall 2504 extends higher upward than the inner wall 2516, suchthat a lid 2510, such as a cap, plug, cover, etc., can be attached tothe outer wall 2504 and be displaced by a small distance from the top ofthe inner wall 2516. A seal 2508 in the form of a silicone wafer, orother elastomeric material, fits within the outer wall 2504 to cover theair permeable blood barrier 2506 and abut the top of the inner wall2516. The seal 2508 covers and seals the air permeable blood barrier2506 and inhibits air from entering the blood sequestration chamber 2520through the air permeable blood barrier 2506. A fulcrum 2512 on anunderside of the lid 2510 allows the seal 2508 to flexibly disconnectfrom the top of the inner wall 2516 when pushed by air displaced fromthe blood sequestration chamber 2520, to allow air to vent from the airpermeable blood barrier 2506 and through the one or more air vents 2514in the outer wall 2504.

FIG. 26A-E illustrate a blood sample optimization system 2600 thatincludes a patient needle 2602 for vascular access to a patient'sbloodstream, a blood sample collection device 2604 to facilitate thecollecting of one or more blood samples for blood testing or bloodcultures, and a conduit 2606 providing a fluid connection between thepatient needle 2602 and the blood sample collection device 2604. Theconduit 2606 can include flexible tubing. In preferred implementations,the blood sample collection device 2604 includes a protective shield2605 that includes a sealed collection needle on which a sealedvacuum-loaded container is placed, which, once pierced by the collectionneedle, draws in a blood sample under vacuum pressure or force throughthe conduit 2006 from the patient needle 2602.

The blood sample optimization system 2600 further includes a bloodsequestration device 2608, located at any point on the conduit 2606between the patient needle 2602 and the blood sample collection device2604. The location of the blood sequestration device 2608 can be basedon a length of the conduit between the blood sequestration device 2608and the patient needle 2602, and the associated volume that lengthprovides.

The blood sequestration device 2608 includes an inlet port 2612 forbeing connected to the conduit 2606 toward the patient needle 2602, andan outlet port 2614 for being connected to the conduit 2606 toward theblood sample collection device 2604. The blood sequestration device 2608includes an outer housing 2616 and an inner housing 2617, both having acylindrical form, and being connected concentrically. The outer housing2616 includes an outer wall 2618 and an inner conduit 2620 that definesa blood sampling channel 2622 to convey blood through the conduit 2606to the blood sampling device 2604. The inner housing 2617 fits snuglybetween the inner conduit 2620 and the outer wall 2618 of the outerhousing, and is rotatable in relation to the outer housing 2616. The fitbetween the outer housing 2616 and the inner housing 2617 can be afriction fit that maintains the housings in a particular position. Theinner housing 2617 defines a blood sequestration chamber 2624,preferably a helical or corkscrew channel around the outer surface ofinner conduit 2620 of the outer housing 2616, and which terminates at anair vent 2628 having an air permeable blood barrier, as shown in FIG.26E.

The blood sequestration chamber 2624 is connected with the bloodsampling channel 2622 via diversion junction 2624 formed in the innerconduit 2620, when the blood sequestration device in a first state,illustrated in FIG. 26C. The protective shield 2606 on the collectionneedle 2604 provides a block for air or blood, enabling a diversion ofan initial aliquot of blood into the blood sequestration chamber 2624 asthe patient's blood pressure overcomes the ambient air pressure in theblood sequestration channel 2624 to displace air therefrom through airvent 2628.

When the inner housing 2617 is rotated relative to the outer housing2616, or vice versa, to a second state, as illustrated in FIG. 26D, theblood sequestration chamber 2624 is shut off from diversion junction2624, enabling a direct path from the patient needle through the conduit2606 to the collection needle 2604, via blood sampling channel 2622. Theouter housing 2616 and/or inner housing 2617 can include ridges orgrooves formed within a portion of their surfaces, to facilitaterelative rotation from the first state to the second state.

FIGS. 27A-D illustrate a blood optimization system 2700 and bloodsequestration device 2702, formed substantially as described withreference to at least FIGS. 15, 16, 17, 18, 19, and 25, but being formedto inhibit a user or other object from touching or blocking an airventing mechanism from a blood sequestration chamber 2720. Air initiallyin the blood sequestration chamber 2720 is displaced by an initialaliquot of blood upon venipuncture, where a patient's blood pressureovercomes the ambient air pressure in the blood sequestration chamber2720. The air venting mechanism includes an air permeable blood barrier2706, such as a porous material or set of materials that allows air toescape but blocks blood from leaving the blood sequestration chamber2720.

The air venting mechanism includes an inner wall 2716 that at leastpartially circumscribes or surrounds the air permeable blood barrier2706, and an outer wall 2704 spaced apart from the inner wall 2716. Acap 2722 is positioned on the air venting mechanism, preferably byhaving a lower cap wall 2728 that fits between the inner wall 2716 andthe outer wall 2704 of the air venting mechanism, and frictionallyabutting either the the inner wall 2716 or the outer wall 2704 or both.The cap 2722 further includes one or more vent holes 2724 or slits,apertures, openings, or the like, which extend through an upper surfaceof the cap 2722 around a downwardly extending plug 2726. The plug 2726is sized and adapted to fit snugly within the space defined by innerwall 2716.

In a first position, as illustrated in FIG. 27C, the cap 2722 isextended from the air venting mechanism to allow air from the bloodsequestration chamber 2720 to exit through the air permeable bloodbarrier 2706 and through the one or more vent holes 2724. Once the airfrom the blood sequestration chamber 2720 has been displaced, i.e., whenthe blood sequestration chamber 2720 is filled with the first aliquot ofpotentially tainted blood from the patient, then the cap 2722 can bepushed down on the air venting mechanism in a second position as shownin FIG. 27D, so that the plug 2726 fits within the inner wall 2716 overthe air permeable blood barrier 2706 to seal the air venting mechanism.In either the first position or the second position, the cap 2722protects the air permeable blood barrier 2706 from outside air or frombeing touched by a user.

FIGS. 28A-F illustrate a blood optimization system 2800 and bloodsequestration device 2802, formed substantially as described withreference to at least FIGS. 15, 16, 17, 18, 19, 25 and 26, but utilizinga multi-layered filter, and in some implementations, a filter withtrapped reactive material, for an air permeable blood barrier. As shownin FIGS. 28C and D, an air permeable blood barrier 2803 includes a firstlayer 2804 of an air permeable but blood impermeable material, and asecond layer 2806 that includes a reactive material, such as ahydrophilic material, for repelling blood while still allowing air topass through both layers. As shown in FIGS. 28E and F, the air permeableblood barrier 2803 can include any number of layers, such as a thirdlayer 2808 formed of the same air permeable but blood impermeablematerial as first layer 2804, while a second layer 2806 includes trappedor embedded blood reactive material.

FIGS. 29A-C illustrate a blood optimization system 2900 and bloodsequestration device 2902, formed substantially as described withreference to at least FIGS. 15, 16, 17, 18, 19, 25 and 26, but in whicha blood sequestration chamber 2904 is at least partially filled with ablood-absorptive material 2906. The blood-absorptive material 2906 canact as a wicking material to further draw in blood to be sequesteredupon venipuncture of the patient, and prior to use of a blood drawingdevice such as a Vacutainer™ or a syringe, or the like.

FIGS. 30A-G illustrate a blood optimization system 2999 and bloodsequestration device 3000, formed substantially as described withreference to at least FIGS. 15, 16, 17, 18, 19, 25 and 26. The bloodsequestration device 3000 includes an inlet port 3002 that can beconnected with a patient needle that is inserted into a patient'svascular system for access to and withdrawing of a blood sample. Theinlet port 3002 may also be connected with tubing or other conduit thatis in turn connected with the patient needle. The inlet port 3002defines an opening into the blood sequestration device 3000, whichopening can be the same cross sectional dimensions as tubing or otherconduit connected with the patient needle or the patient needle itself.For instance, the opening can be circular with a diameter ofapproximately 0.045 inches, but can have a diameter of between 0.01inches or less to 0.2 inches or more.

The inlet port 3002 can also include a sealing or fluid-tight connectoror connection, such as threading or Luer fitting, or the like. In someimplementations, tubing or other conduit associated with the patientneedle can be integral with the inlet port 3002, such as by co-molding,gluing, laser weld, or thermally bonding the parts together. In thismanner, the blood sequestration device 3000 can be fabricated and soldwith the patient needle and/or tubing as a single unit, eliminating theneed for connecting the patient needle to the blood sequestration device3000 at the time of blood draw or sampling.

The blood sequestration device 3000 further includes an outlet port3004, which defines an opening out of the blood sequestration device3000 and to the blood sample collection device. The outlet port 3004 mayalso be connected with tubing or other conduit that is in turn connectedwith the blood sequestration device, and may also include a sealing orfluid-tight connector or connection, such as threading or Luer fitting,or the like. Accordingly, as discussed above, the blood sequestrationdevice 3000 can be fabricated and sold with the patient needle and/ortubing and the blood sample collection device as a single unit,eliminating the need for connecting the patient needle and the bloodsample collection device to the blood sequestration device 3000 at thetime of blood draw or sampling.

The blood sequestration device 3000 further includes a sampling channel3006 between the inlet port 3002 and the outlet port 3004, and asequestration chamber 3008 that is connected to and split off ordiverted from the sampling channel 3006 at any point between the inletport 3002 and the outlet port 3004. The sampling channel 3006 functionsas a blood sampling pathway once a first aliquot of blood has beensequestered in the sequestration chamber 3008. The sampling channel 3006can be any sized, shaped or configured channel, or conduit. In someimplementations, the sampling channel 3006 has a substantially similarcross sectional area as the opening of the inlet port 3002. In otherimplementations, the sampling channel 3006 can gradually widen from theinlet port 3002 to the outlet port 3004. The sequestration chamber 3008may have a larger cross section to form a big reservoir toward thesequestration channel path so that the blood will want to enter thereservoir first versus entering a smaller diameter on the samplingchannel 3006.

In some exemplary implementations, the diversion between the samplingchannel 3006 and the sequestration chamber 3008 is by diverter junction3007. Diverter junction 3007 may be a substantially Y-shaped, T-shaped,or U-shaped. In some preferred exemplary implementations, and as shownin FIG. 17A-17B, the diverter junction 3007 is configured such that theflow out of the inlet port 3002 is preferentially directed toward thesequestration chamber 3008. The sequestration chamber 3008 may alsoinclude or form a curve or ramp to direct the initial blood flow towardand into the sequestration chamber 3008.

The sequestration chamber 3008 is preferably maintained at atmosphericpressure, and includes a vent 3010 at or near a distal end of thesequestration chamber 3008. The vent 3010 may include an air permeableblood barrier 3012 as described above.

The blood sequestration device 3000 can include a housing 3001 that canbe formed of multiple parts or a single, unitary part. In someimplementations, and as illustrated FIG. 30F, the housing 3001 includesa top member 3020 and a bottom member 3022 that are mated together. Theblood sequestration device 3000 can also include a gasket or othersealing member (not shown) so that when the top member 3020 ismechanically attached with the bottom member 3022, the interface betweenthe two is sealed by the gasket or sealing member. The bottom member3022 can include grooves, channels, locks, conduits or other pathwayspre-formed therein, such as by an injection molding process or byetching, cutting, drilling, etc., to form the sampling channel 3006, thesequestration chamber 3008, and diverter junction 3007.

The sequestration chamber 3008 may have a larger cross section than thesampling channel 3006 so that the blood will preferentially move intothe sequestration chamber first versus entering a smaller diameter onthe sampling channel 3006.

In some implementations, the sampling channel 3006 and the sequestrationchamber 3008 are formed by grooves, channels, locks or other pathwaysformed in housing 3001. The housing 3001 can be made of rubber, plastic,metal or any other suitable material. The housing 3001 can be formed ofa clear or translucent material, or of an opaque or non-translucentmaterial. In other implementations, the housing 3001 can be mostlyopaque or non-translucent, while the housing surface directly adjacentto the sampling channel 3006 and/or the sequestration chamber 3008 maybe clear or translucent, giving a practitioner a visual cue or sign thatthe sequestration chamber 3008 is first filled to the extent necessaryor desired, and/or then a visual cue or sign that the sequestered bloodremains sequestered while a clean sample of blood is drawn through thesampling channel 3006. Other visual cues or signs of the sequestrationcan include, without limitation: the air permeable blood barrier 3012turning a different color upon contact, saturation, or partialsaturation with blood; a color-coded tab or indicator at any point alongor adjacent to the sequestration chamber; an audible signal; a vibratorysignal; or other signal.

The air permeable blood barrier 3012 can be covered with, or surroundedby, a cap 3032. The cap 3032 can be sized and configured to inhibit auser from touching the air permeable blood barrier 3012 with theirfinger or other external implement, while still allowing air to exit theair permeable blood barrier 3012 as the air is displaced from thesequestration chamber 3008. The cap 3032 can be constructed to inhibitor prevent accidental exposure of the filter to environmental fluids orsplashes. This can be accomplished in a variety of mechanical waysincluding but not limited to the addition of a hydrophobic membrane tothe protective cover.

The air venting mechanism includes a wall 3030 that at least partiallycircumscribes or surrounds the air permeable blood barrier 3012. Thewall 3030 can have one or more air vents formed therein. The cap 3032covers wall 3030 and can be snapped, glued, or otherwise attached inplace. A seal 3017 in the form of a silicone wafer, or other elastomericmaterial, fits within the wall 3030 to cover the air permeable bloodbarrier 3012 and abut the top of the wall 3030. The seal 3017 covers andseals the air permeable blood barrier 3012 and inhibits air fromentering the blood sequestration chamber 3008 through the air permeableblood barrier 3012. A fulcrum 3012 on an underside of the cap 3032allows the seal 3008 to flexibly disconnect from the top of the innerwall 3016 when pushed by air displaced from the blood sequestrationchamber 3008, to allow air to vent from the air permeable blood barrier3012 and through the one or more air vents in the wall 3030 and/or cap3032.

In use, the blood sequestration device 3000 includes a sampling channel3006 and a sequestration chamber 3008. Both pathways are initiallyair-filled at atmospheric pressure, but the sampling channel 3006 isdirected to an outlet port 3004 that will be initially sealed by aVacutainer or other such sealed blood sampling device, and thesequestration chamber 3008 terminates at a vent 3010 to atmosphere thatincludes an air permeable blood barrier 3012.

After a venipuncture by a patient needle of a patient (not shown), whichcould gather a number of pathogens from the patient's skin, a firstamount of the patient's blood with those pathogens will pass throughinlet port 3002 of blood sequestration device 3000. This initial volumeof potentially contaminated blood will preferentially flow into thesequestration chamber 3008 by finding the path of least resistance. Thepatient's own blood pressure overcomes the atmospheric pressure in thevented sequestration chamber 3008 to displace air therein through theair permeable blood barrier 3012, but is not sufficient to overcome theair pressure that builds up in the sealed sampling channel 3006. Invarious exemplary embodiments, the sequestration chamber 3008 andsampling channel 3006 can be configured such that the force generated bythe patient's blood pressure is sufficient to overcome any effect ofgravity, regardless of the blood sequestration device's orientation.

Eventually, the sequestration chamber 3008 fills with blood thatdisplaces air through the air permeable blood barrier 3012. Once theblood contacts the air permeable blood barrier, the blood interacts withthe air permeable blood barrier 3012 material to completely or partiallyseal the vent 3010. A signal or indication may be provided that thepractitioner can now utilize the Vacutainer or other blood samplingdevice.

Upon filling the blood sequestration pathway 3008 but prior to use ofthe Vacutainer or other blood sample collection device, the patient'sblood pressure may drive compression of the air in the sampling channel3006, possibly resulting in a small amount of blood moving past thediversion point into the sampling channel 3006, queuing up theuncontaminated blood to be drawn through the sampling channel 3006.

In yet another aspect, the blood sequestration chamber and/or bloodsampling channel, or other component, of any of the implementationsdescribed herein, can provide a visually discernable warning or resultin a component adapted for operative fluid communication with the flashchamber of an introducer for an intravenous catheter into a blood vesselof a patient. The device and method provides a visually discernablealert when blood from the patient communicates with a test componentreactive to communicated blood plasma, to visually change. The reactionwith the blood or the plasma occurs depending on one or a plurality ofreagents positioned therein configured to test for blood contents,substances or threshold high or low levels thereof, to visually changein appearance upon a result.

In yet other aspects, the blood sequestration chamber and/or bloodsampling channel can be sized and adapted to provide a particularvolumetric flow of blood, either during the sequestration process and/orthe sampling process.

FIG. 31A illustrates yet another implementation of a blood sequestrationdevice 3099 of a blood optimization system 3100, where the bloodsequestration device 3099 is connected on a sampling tube between apatient needle 3103 and a sampling device 3105, which typically includesa resealable sampling or patient needle 3107. Referring also to FIGS.31B-D, the blood sequestration device 3099 includes an inlet port 3102that can be connected with a patient needle that is inserted into apatient's vascular system for access to and withdrawing of a bloodsample. The inlet port 3102 may also be connected with tubing or otherconduit that is in turn connected with the patient needle. The inletport 3102 defines an opening into the blood sequestration device 3100,which opening can be the same cross sectional dimensions as tubing orother conduit connected with the patient needle or the patient needleitself. For instance, the opening can be circular with a diameter ofapproximately 0.045 inches, but can have a diameter of between 0.01inches or less to 0.2 inches or more.

The inlet port 3102 can also include a sealing or fluid-tight connectoror connection, such as threading or Luer fitting, or the like. In someimplementations, tubing or other conduit associated with the patientneedle can be integral with the inlet port 3102, such as by co-molding,gluing, laser weld, or thermally bonding the parts together. In thismanner, the blood sequestration device 3099 can be fabricated and soldwith the patient needle and/or tubing as a single unit, eliminating theneed for connecting the patient needle to the blood sequestration device3099 at the time of blood draw or sampling.

The blood sequestration device 3099 further includes an outlet port3104, which defines an opening out of the blood sequestration device3099 and to the blood sample collection device. The outlet port 3104 mayalso be connected with tubing or other conduit that is in turn connectedwith the blood sequestration device, and may also include a sealing orfluid-tight connector or connection, such as threading or Luer fitting,or the like. Accordingly, as discussed above, the blood sequestrationdevice 3099 can be fabricated and sold with the patient needle and/ortubing and the blood sample collection device as a single unit,eliminating the need for connecting the patient needle and the bloodsample collection device to the blood sequestration device 3099 at thetime of blood draw or sampling.

The blood sequestration device 3099 further includes a sampling channel3106 between the inlet port 3102 and the outlet port 3104, and asequestration chamber 3108 that is connected to and split off ordiverted from the sampling channel 3106 at any point between the inletport 3102 and the outlet port 3104. The sampling channel 3106 functionsas a blood sampling pathway once a first aliquot of blood has beensequestered in the sequestration chamber 3108. The sampling channel 3106can be any sized, shaped or configured channel, or conduit. In someimplementations, the sampling channel 3106 has a substantially similarcross sectional area as the opening of the inlet port 3102. In otherimplementations, the sampling channel 3106 can gradually widen from theinlet port 3102 to the outlet port 3104. The sequestration chamber 3108may have a larger cross section to form a big reservoir toward thesequestration channel path so that the blood will want to enter thereservoir first versus entering a smaller diameter on the samplingchannel 3106.

In some exemplary implementations, the diversion between the samplingchannel 3106 and the sequestration chamber 3108 is by diverter junction3107. Diverter junction 3107 may be a substantially Y-shaped, T-shaped,or U-shaped junction. In some preferred exemplary implementations, andas shown in FIG. 17A-17B, the diverter junction 3107 is configured suchthat fluid flow into and then out of the inlet port 3102 ispreferentially directed toward the sequestration chamber 3108. Thispreferential direction can be assisted by the sequestration chamber 3108being initially filled with air at atmospheric or near-atmosphericpressure, which air can be displaced by the incoming fluid such asblood. The sequestration chamber 3108 may also include or form a curveor ramp to direct the initial blood flow toward and into thesequestration chamber 3108. Further, the sequestration chamber 3108 mayhave a larger cross section than the sampling channel 3106 so that theblood will preferentially move into the sequestration chamber firstversus entering a smaller diameter on the sampling channel 3106.

The blood sequestration device 3099 can include a housing 3101 that canbe formed of multiple parts or a single, unitary part. In someimplementations, and as illustrated FIG. 32, the housing 3101 includes atop member 3120 and a bottom member 3122 that are mated together. Theblood sequestration device 3099 can also include a gasket or othersealing member (not shown) so that when the top member 3120 ismechanically attached with the bottom member 3122, the interface betweenthe two is sealed by the gasket or sealing member. The bottom member3122 can include grooves, channels, locks, conduits or other pathwayspre-formed therein, such as by an injection molding process or byetching, cutting, drilling, etc., to form the sampling channel 3106, thesequestration chamber 3108, and diverter junction 3107.

In some implementations, the sampling channel 3106 and the sequestrationchamber 3108 are formed by grooves, channels, locks or other pathwaysformed in housing 3101, such as by corresponding grooves, channels,locks or other pathways formed in either or both the top member 3120 orbottom member 3122 of the housing 3101. The housing 3101 can be made ofrubber, plastic, metal or any other suitable material. The housing 3101can be formed of a clear or translucent material, or of an opaque ornon-translucent material. In other implementations, the housing 3101 canbe mostly opaque or non-translucent, while the housing surface directlyadjacent to the sampling channel 3106 and/or the sequestration chamber3108 may be clear or translucent, giving a practitioner a visual cue orsign that the sequestration chamber 3108 is first filled to the extentnecessary or desired, and/or then a visual cue or sign that thesequestered blood remains sequestered while a clean sample of blood isdrawn through the sampling channel 3106. Other visual cues or signs ofthe sequestration can include, without limitation: the air permeableblood barrier 3112 turning a different color upon contact, saturation,or partial saturation with blood; a color-coded tab or indicator at anypoint along or adjacent to the sequestration chamber; an audible signal;a vibratory signal; or other signal.

The sequestration chamber 3108 is preferably maintained at atmosphericor near-atmospheric pressure, and includes a venting mechanism 3110 ator near a distal end of the sequestration chamber 3108. The ventingmechanism 3110 may include an air permeable blood barrier 3112, such asa porous plug that self-seals to blood or other fluid upon contact withblood or other fluid. The venting mechanism 3110 further includes one ormore vents, holes, apertures, slits, openings, or the like, for allowingair to escape or be pressured out of the sequestration chamber 3108.

As shown best in FIG. 32, the air permeable blood barrier 3012 can becovered with, or surrounded by, a cap 3032. The cap 3032 can be sizedand configured to inhibit a user from touching the air permeable bloodbarrier 3012 with their finger or other external implement, while stillallowing air to exit the air permeable blood barrier 3012 as the air isdisplaced from the sequestration chamber 3008. The cap 3032 can beconstructed to inhibit or prevent accidental exposure of the filter toenvironmental fluids or splashes. This can be accomplished in a varietyof mechanical ways including but not limited to the addition of ahydrophobic membrane to the protective cover.

As shown in FIGS. 31E, 32, the venting mechanism 3110 includes a valve3140 that encloses any exit openings, apertures or vents of the ventingmechanism, but which allows air to escape the sequestration chamber3108, as illustrated. The valve 3140 is preferably a one-way valve, suchas an umbrella valve as shown in FIGS. 33A-33B, and which can be placedbefore the air-permeable blood barrier or plug at the vent of the device3099. The umbrella valve includes a central stem that fits into anopening 3144 or receptacle in the top housing 3122, and a rounded valvemember that flexibly opens up under fluid pressure such as from air orblood, but then re-closes to inhibit a reverse direction of air, bloodor other fluid. Alternatively, the valve 3140 can be a duckbill valve asshown in FIGS. 34 and 35.

The air venting mechanism includes a wall 3131 that at least partiallycircumscribes or surrounds the air permeable blood barrier 3112. Thewall 3131 can have one or more air vents formed therein. The cap 3032can be inserted over (as in FIG. 34) or within (as in FIG. 32) the wall3130, and can be snapped, glued, or otherwise attached in place.

In use, the blood sequestration device 3100 includes a sampling channel3106 and a sequestration chamber 3108. Both pathways are initiallyair-filled at atmospheric pressure, but the sampling channel 3106 isdirected to an outlet port 3104 that will be initially sealed by aVacutainer or other such sealed blood sampling device, and thesequestration chamber 3108 terminates at a vent 3110 to atmosphere thatincludes an air permeable blood barrier 3112.

After a venipuncture by a patient needle of a patient (not shown), whichcould gather a number of pathogens from the patient's skin, a firstamount of the patient's blood with those pathogens will pass throughinlet port 3102 of blood sequestration device 3100. This initial volumeof potentially contaminated blood will preferentially flow into thesequestration chamber 3108 by finding the path of least resistance. Thepatient's own blood pressure overcomes the atmospheric pressure in thevented sequestration chamber 3108 to displace air therein through theair permeable blood barrier 3112, but is not sufficient to overcome theair pressure that builds up in the sealed sampling channel 3106. Invarious exemplary embodiments, the sequestration chamber 3108 andsampling channel 3106 can be configured such that the force generated bythe patient's blood pressure is sufficient to overcome any effect ofgravity, regardless of the blood sequestration device's orientation.

Eventually, the sequestration chamber 3108 fills with blood thatdisplaces air through the air permeable blood barrier 3112. Once theblood contacts the air permeable blood barrier, the blood interacts withthe air permeable blood barrier 3112 material to completely or partiallyseal the vent 3110. A signal or indication may be provided that thepractitioner can now utilize the Vacutainer or other blood samplingdevice.

Upon filling the blood sequestration pathway 3108 but prior to use ofthe Vacutainer or other blood sample collection device, the patient'sblood pressure may drive compression of the air in the sampling channel3106, possibly resulting in a small amount of blood moving past thediversion point into the sampling channel 3106, queuing up theuncontaminated blood to be drawn through the sampling channel 3106.

FIGS. 36 A-D illustrate a blood optimization system 3600 and bloodsequestration device 3602, formed substantially as described above, yetwith a manually-actuated closure mechanism proximate an air-permeableblood barrier and/or air vent. The blood sequestration device 3602includes an inlet port that can be connected with a patient needledevice 3604, maybe via a portion of tubing 3608, for insertion of aneedle into a patient's vascular system for access to and withdrawing ofa blood sample. The patient needle device 3604 can have a protectivecover, retractable needle, and opposing “wings” for manipulating theretractable needle as well as providing an anchor to the patient's skinproximate the venipuncture site.

The inlet port may also be connected with tubing 3608 or other conduitthat is in turn connected with the patient needle device 3604. The inletport defines an opening into the blood sequestration device 3602, whichopening can be the same cross sectional dimensions as tubing or otherconduit connected with the patient needle or the patient needle itself,as described above. The inlet port can also include a sealing orfluid-tight connector or connection, such as threading or Luer fitting,or the like.

The blood sequestration device 3602 further includes an outlet port,which defines an opening out of the blood sequestration device 3602 andto a blood sample collection device 3606. The blood sample collectiondevice 3606 generally includes a sampling needle that is sealed by athin pierce-able membrane or the like, and on which a collection devicesuch as a Vacutainer™ can be placed, for providing vacuum-forcedcollection of a blood sample. The outlet port may be connected withtubing or other conduit, and may also include a sealing or fluid-tightconnector or connection, such as threading or Luer fitting, or the like.Accordingly, as discussed above, the blood sequestration device 3602 canbe fabricated and sold with the patient needle device 3604 and/or tubingand/or the blood sample collection device 3606 as a single unit,eliminating the need for connecting the patient needle and the bloodsample collection device to the blood sequestration device 3602 at thetime of blood draw or sampling.

As described with reference to various implementations herein, the bloodsequestration device 3602 further includes a sampling channel betweenthe inlet port and the outlet port, and a sequestration chamber that isconnected to and split off or diverted from the sampling channel at anypoint between the inlet port and the outlet port. The sampling channelfunctions as a blood sampling pathway once a first aliquot of blood hasbeen sequestered in the sequestration chamber. The sampling channel canbe any sized, shaped or configured channel, or conduit. In someimplementations, the sampling channel has a substantially similar crosssectional area as the opening of the inlet port. In otherimplementations, the sampling channel can gradually widen from the inletport to the outlet port. The sequestration chamber may have a largercross section to form a big reservoir toward the sequestration channelpath so that the blood will want to enter the reservoir first versusentering a smaller diameter on the sampling channel.

In some exemplary implementations, the diversion between the samplingchannel and the sequestration chamber is by a diverter junction. Thediverter junction may be substantially Y-shaped, T-shaped, or U-shaped,or the like. In some implementations, and as exemplified in FIG.17A-17B, the diverter junction is configured such that the flow out ofthe inlet port is preferentially directed toward or biased toward thesequestration chamber. The blood sequestration device 3602 can use othertypes of diverters, junctions or flow-biasing mechanisms. Thesequestration chamber may also include or form a curve or ramp to directthe initial blood flow toward and into the sequestration chamber.

The blood sequestration device 3602 can include a housing that can beformed of multiple parts or a single, unitary part. In someimplementations, the housing includes a top member and a bottom memberthat are mated together. The blood sequestration device can also includea gasket or other sealing member (not shown) so that when the top memberis mechanically attached with the bottom member, the interface betweenthe two is sealed by the gasket or sealing member. The bottom member caninclude grooves, channels, locks, conduits or other pathways pre-formedtherein, such as by an injection molding process or by etching, cutting,drilling, etc., to form the sampling channel, the sequestration chamber,and diverter junction.

In some implementations, the sampling channel and the sequestrationchamber are formed by grooves, channels, locks or other pathways formedin housing. The housing can be made of rubber, plastic, metal or anyother suitable material. The housing can be formed of a clear ortranslucent material, or of an opaque or non-translucent material. Inother implementations, the housing can be mostly opaque ornon-translucent, while the housing surface directly adjacent to thesampling channel and/or the sequestration chamber may be clear ortranslucent, giving a practitioner a visual cue or sign that thesequestration chamber is first filled to the extent necessary ordesired, and/or then a visual cue or sign that the sequestered bloodremains sequestered while a clean sample of blood is drawn through thesampling channel. Other visual cues or signs of the sequestration caninclude, without limitation: the air permeable blood barrier turning adifferent color upon contact, saturation, or partial saturation withblood; a color-coded tab or indicator at any point along or adjacent tothe sequestration chamber; an audible signal; a vibratory signal; orother signal.

The sequestration chamber is preferably maintained at atmosphericpressure, and includes a vent 3609 at or near a distal end of thesequestration chamber. The vent 3609 may include an air permeable bloodbarrier as described above. The vent 3609 is preferably located on a topsurface of a housing of the blood sequestration device 3602. The vent3609 and/or air permeable blood barrier can be circumscribed by a wallor other separation mechanism.

As shown in FIGS. 36B-D, the blood sequestration device 3602 can includea cover 3610 that is adapted to cover and enclose, or otherwise seal thevent 3609 once the initial aliquot of blood has filled the sequestrationchamber and has displaced air through the vent 3609. The cover 3610 canhave an initial configuration, or open mode, of being displaced from thevent 3609 to allow air to escape from the blood sequestration device3602, and in particular the blood sequestration chamber. The cover 3610can also have a second configuration, or closed mode, where a secondpart of the cover 3610 covers and at least partially seals the vent3609, at least to the extent that blood should not escape past the cover3610 in its closed mode or second configuration.

In some implementations, the cover 3610 can include an adhesive label,at least part of which is initially adhered to a surface of the housingof the blood sequestration device 3602 proximate the vent 3609, and thesecond part of the adhesive label seals around the vent 3609. The cover3610 can be actuated from the initial configuration to the secondconfiguration, or from the open mode to the closed mode, by use of arelease mechanism 3612. In some implementations, the release mechanism3612 can include a liner, having a first portion lining or backing anunderside of the second part of the adhesive label, and a second portionof the liner extending outward to form a tab that can be grabbed by thefingers of a user, and pulled away from the second part of the adhesivelabel, in a gradual manner, to lay down and adhere the second part ofthe adhesive label to the housing of the blood sequestration device 3602around the vent 3609.

Accordingly, for an exemplary implementation in use, the bloodsequestration device 3602 includes a sampling channel and asequestration chamber. Both pathways are initially air-filled atatmospheric pressure, but the sampling channel is directed to an outletport that will be initially sealed by a Vacutainer or other such sealedblood sampling device, and the sequestration chamber terminates at avent to atmosphere that includes an air permeable blood barrier. After avenipuncture by a patient needle of a patient (not shown), which couldgather a number of pathogens from the patient's skin, a first amount ofthe patient's blood with those pathogens will pass through inlet port ofblood sequestration device. This initial volume of potentiallycontaminated blood will preferentially flow into the sequestrationchamber by finding the path of least resistance. The patient's own bloodpressure overcomes the atmospheric pressure in the vented sequestrationchamber to displace air therein through the air permeable blood barrier,but is not sufficient to overcome the air pressure that builds up in thesealed sampling channel. In various exemplary embodiments, thesequestration chamber and sampling channel can be configured such thatthe force generated by the patient's blood pressure is sufficient toovercome any effect of gravity, regardless of the blood sequestrationdevice's orientation.

Eventually, the sequestration chamber fills with blood that displacesair through the air permeable blood barrier. Once the blood contacts theair permeable blood barrier, the blood interacts with the air permeableblood barrier material to completely or partially seal the vent. Toaugment such seal, or to seal itself, a user can grab a distal end ofthe release liner, and pull it away from the underside of the secondpart of the adhesive label until the second part of the adhesive labelexposes an adhesive to a top surface of the housing proximate the ventand/or air permeable blood barrier. Once so adhered, as shown in FIG.36D, the vent 3609 will not allow air to reenter the blood sequestrationchamber, the user can now use the blood collection device 3606 tocollect further blood, which bypasses the sequestration chamber of theblood sequestration device 3602.

Other manually-actuated closure mechanisms can be used. For example,FIGS. 37A-E illustrate a blood optimization system 3700 and bloodsequestration device 3702, formed substantially as described above, yetwith a manually-actuated closure mechanism proximate an air-permeableblood barrier and/or air vent. The blood sequestration device 3702includes an inlet port that can be connected with a patient needledevice 3704 for insertion of a needle into a patient's vascular systemfor access to and withdrawing of a blood sample. The patient needledevice 3704 can have a protective cover, retractable needle, andopposing “wings” for manipulating the retractable needle as well asproviding an anchor to the patient's skin proximate the venipuncturesite.

The inlet port may also be connected with tubing 3708 or other conduitthat is in turn connected with the patient needle device 3704. The inletport defines an opening into the blood sequestration device 3702, whichopening can be the same cross sectional dimensions as tubing or otherconduit connected with the patient needle or the patient needle itself,as described above. The inlet port can also include a sealing orfluid-tight connector or connection, such as threading or Luer fitting,or the like.

The blood sequestration device 3702 further includes an outlet port,which defines an opening out of the blood sequestration device 3702 andto a blood sample collection device 3706. The blood sample collectiondevice 3706 generally includes a sampling needle that is sealed by athin pierce-able membrane or the like, and on which a collection devicesuch as a Vacutainer™ can be placed, for providing vacuum-forcedcollection of a blood sample. The outlet port may be connected withtubing or other conduit, and may also include a sealing or fluid-tightconnector or connection, such as threading or Luer fitting, or the like.Accordingly, as discussed above, the blood sequestration device 3702 canbe fabricated and sold with the patient needle device 3704 and/or tubingand/or the blood sample collection device 3706 as a single unit,eliminating the need for connecting the patient needle and the bloodsample collection device to the blood sequestration device 3702 at thetime of blood draw or sampling.

As described with reference to various implementations herein, the bloodsequestration device 3702 further includes a sampling channel betweenthe inlet port and the outlet port, and a sequestration chamber that isconnected to and split off or diverted from the sampling channel at anypoint between the inlet port and the outlet port. The sampling channelfunctions as a blood sampling pathway once a first aliquot of blood hasbeen sequestered in the sequestration chamber. The sampling channel canbe any sized, shaped or configured channel, or conduit. In someimplementations, the sampling channel has a substantially similar crosssectional area as the opening of the inlet port. In otherimplementations, the sampling channel can gradually widen from the inletport to the outlet port. The sequestration chamber may have a largercross section to form a big reservoir toward the sequestration channelpath so that the blood will want to enter the reservoir first versusentering a smaller diameter on the sampling channel. The sequestrationchamber can be linear, curvilinear, or any other shape.

In some exemplary implementations, the diversion between the samplingchannel and the sequestration chamber is by a diverter junction. Thediverter junction may be substantially Y-shaped, T-shaped, or U-shaped,or the like. In some implementations, and as exemplified in FIG.17A-17B, the diverter junction is configured such that the flow out ofthe inlet port is preferentially directed toward or biased toward thesequestration chamber. The blood sequestration device 3702 can use othertypes of diverters, junctions or flow-biasing mechanisms. Thesequestration chamber may also include or form a curve or ramp to directthe initial blood flow toward and into the sequestration chamber.

The blood sequestration device 3702 can include a housing that can beformed of multiple parts or a single, unitary part. In someimplementations, the housing includes a top member and a bottom memberthat are mated together. The blood sequestration device can also includea gasket or other sealing member (not shown) so that when the top memberis mechanically attached with the bottom member, the interface betweenthe two is sealed by the gasket or sealing member. The bottom member caninclude grooves, channels, locks, conduits or other pathways pre-formedtherein, such as by an injection molding process or by etching, cutting,drilling, etc., to form the sampling channel, the sequestration chamber,and diverter junction.

In some implementations, the sampling channel and the sequestrationchamber are formed by grooves, channels, locks or other pathways formedin housing. The housing can be made of rubber, plastic, metal or anyother suitable material. The housing can be formed of a clear ortranslucent material, or of an opaque or non-translucent material. Inother implementations, the housing can be mostly opaque ornon-translucent, while the housing surface directly adjacent to thesampling channel and/or the sequestration chamber may be clear ortranslucent, giving a practitioner a visual cue or sign that thesequestration chamber is first filled to the extent necessary ordesired, and/or then a visual cue or sign that the sequestered bloodremains sequestered while a clean sample of blood is drawn through thesampling channel. Other visual cues or signs of the sequestration caninclude, without limitation: the air permeable blood barrier turning adifferent color upon contact, saturation, or partial saturation withblood; a color-coded tab or indicator at any point along or adjacent tothe sequestration chamber; an audible signal; a vibratory signal; orother signal.

The sequestration chamber is preferably maintained at atmosphericpressure, and includes a vent 3709 at or near a distal end of thesequestration chamber. The vent 3709 may include an air permeable bloodbarrier as described above. The vent 3709 is preferably located on a topsurface of a housing of the blood sequestration device 3702. The vent3709 and/or air permeable blood barrier can be circumscribed by a wallor other separation mechanism. As shown in FIGS. 37B and C, the vent3709 can include a closure mechanism 3710. In some implementations, theclosure mechanism 3710 is a raised portion that is raised from an outersurface of the housing. The raised portion 3710 can include a wall thatcircumscribes the vent 3709 and/or the air-permeable blood barriertherein. The wall can have one or more air vents formed therein. Theraised portion can also include a top surface that is shaped, curvedand/or adapted to receive a part of a human finger or other appendage toseal off an opening that forms or is included in the vent 3709.

As shown in FIGS. 37C-E, the closure mechanism 3710 of the vent 3709 canbe configured to receive a part of a human finger or other appendage toclose off and/or seal the vent 3709, preferably once the sequestrationchamber is filled with a first desired aliquot of possibly contaminatedblood. In some configuration, the closure mechanism 3710. In someimplementations, the closure mechanism simply defines a surface tointerface with another object, such as a human fingertip, a cotton swab,a piece of tape, or any other object, to seal any vents, apertures,openings, holes, or the like, of which the vent 3709 is comprised.

Accordingly, for an exemplary implementation of the blood sequestrationdevice 3702 in use, a sampling channel and a sequestration chamber areinitially air-filled at atmospheric pressure, but the sampling channelis directed to an outlet port that will be initially sealed by aVacutainer or other such sealed blood sampling device, and thesequestration chamber terminates at a vent to atmosphere that includesan air permeable blood barrier. After a venipuncture by a patient needleof a patient (not shown), which could gather a number of pathogens fromthe patient's skin, a first amount of the patient's blood with thosepathogens will pass through inlet port of blood sequestration device.This initial volume of potentially contaminated blood willpreferentially flow into the sequestration chamber by finding the pathof least resistance. The patient's own blood pressure overcomes theatmospheric pressure in the vented sequestration chamber to displace airtherein through the air permeable blood barrier, but is not sufficientto overcome the air pressure that builds up in the sealed samplingchannel. In various exemplary embodiments, the sequestration chamber andsampling channel can be configured such that the force generated by thepatient's blood pressure is sufficient to overcome any effect ofgravity, regardless of the blood sequestration device's orientation.

Eventually, the sequestration chamber fills with blood that displacesair through the air permeable blood barrier, which may or may not be acomplete barrier or seal against blood. Once the blood contacts the airpermeable blood barrier, the blood interacts with the air permeableblood barrier material to at least partially seal the vent. To augmentsuch seal, or to seal itself, a user can place another object, such as ahuman fingertip, a cotton swab, a piece of tape, or any other object, toseal any vents, apertures, openings, holes, or the like, of which thevent 3709 is comprised. Once so placed, the vent 3709 will not allow airto reenter the blood sequestration chamber, the initial aliquot of bloodwill be sequestered, and the user can now use the blood collectiondevice 3706 to collect further blood, which bypasses the sequestrationchamber of the blood sequestration device 3702.

Still other manually-actuated closure mechanisms can be used. Forexample, FIGS. 38A-E illustrate a blood optimization system 3800 andblood sequestration device 3802, formed substantially as describedabove, yet with a manually-actuated closure mechanism in the form of acap 3180 to enclose and/or seal air-permeable blood barrier and/or airvent. The blood sequestration device 3802 includes an inlet port thatcan be connected with a patient needle device 3804 for insertion of aneedle into a patient's vascular system for access to and withdrawing ofa blood sample. The patient needle device 3804 can have a protectivecover, retractable needle, and opposing “wings” for manipulating theretractable needle as well as providing an anchor to the patient's skinproximate the venipuncture site.

The inlet port may also be connected with tubing 3808 or other conduitthat is in turn connected with the patient needle device 3804. The inletport defines an opening into the blood sequestration device 3802, whichopening can be the same cross sectional dimensions as tubing or otherconduit connected with the patient needle or the patient needle itself,as described above. The inlet port can also include a sealing orfluid-tight connector or connection, such as threading or Luer fitting,or the like.

The blood sequestration device 3802 further includes an outlet port,which defines an opening out of the blood sequestration device 3802 andto a blood sample collection device 3806. The blood sample collectiondevice 3806 generally includes a sampling needle that is sealed by athin pierce-able membrane or the like, and on which a collection devicesuch as a Vacutainer™ can be placed, for providing vacuum-forcedcollection of a blood sample. The outlet port may be connected withtubing or other conduit, and may also include a sealing or fluid-tightconnector or connection, such as threading or Luer fitting, or the like.Accordingly, as discussed above, the blood sequestration device 3802 canbe fabricated and sold with the patient needle device 3804 and/or tubingand/or the blood sample collection device 3806 as a single unit,eliminating the need for connecting the patient needle and the bloodsample collection device to the blood sequestration device 3802 at thetime of blood draw or sampling.

As described with reference to various implementations herein, the bloodsequestration device 3802 further includes a sampling channel betweenthe inlet port and the outlet port, and a sequestration chamber that isconnected to and split off or diverted from the sampling channel at anypoint between the inlet port and the outlet port. The sampling channelfunctions as a blood sampling pathway once a first aliquot of blood hasbeen sequestered in the sequestration chamber. The sampling channel canbe any sized, shaped or configured channel, or conduit. In someimplementations, the sampling channel has a substantially similar crosssectional area as the opening of the inlet port. In otherimplementations, the sampling channel can gradually widen from the inletport to the outlet port. The sequestration chamber may have a largercross section to form a big reservoir toward the sequestration channelpath so that the blood will want to enter the reservoir first versusentering a smaller diameter on the sampling channel. The sequestrationchamber can be linear, curvilinear, or any other shape.

In some exemplary implementations, the diversion between the samplingchannel and the sequestration chamber is by a diverter junction. Thediverter junction may be substantially Y-shaped, T-shaped, or U-shaped,or the like. In some implementations, and as exemplified in FIG.17A-17B, the diverter junction is configured such that the flow out ofthe inlet port flows first to, is preferentially directed toward, or isbiased toward the sequestration chamber. For instance, the diverterjunction of the implementations of any of the blood sequestrationdevices described or shown herein can be configured or formed such thata first portion of blood follows a path of least resistance toward thesequestration chamber. The blood sequestration device 3802 can use othertypes of diverters, junctions or flow-biasing mechanisms. Thesequestration chamber may also include or form a curve or ramp to createthe path of least resistance and direct the initial blood flow towardand into the sequestration chamber, regardless of any positioning ororientation of the blood sequestration device.

The blood sequestration device 3802 can include a housing that can beformed of multiple parts or a single, unitary part. In someimplementations, the housing includes a top member and a bottom memberthat are mated together. The blood sequestration device can also includea gasket or other sealing member (not shown) so that when the top memberis mechanically attached with the bottom member, the interface betweenthe two is sealed by the gasket or sealing member. The bottom member caninclude grooves, channels, locks, conduits or other pathways pre-formedtherein, such as by an injection molding process or by etching, cutting,drilling, etc., to form the sampling channel, the sequestration chamber,and diverter junction.

In some implementations, the sampling channel and the sequestrationchamber are formed by grooves, channels, locks or other pathways formedin housing. The housing can be made of rubber, plastic, metal or anyother suitable material. The housing can be formed of a clear ortranslucent material, or of an opaque or non-translucent material. Inother implementations, the housing can be mostly opaque ornon-translucent, while the housing surface directly adjacent to thesampling channel and/or the sequestration chamber may be clear ortranslucent, giving a practitioner a visual cue or sign that thesequestration chamber is first filled to the extent necessary ordesired, and/or then a visual cue or sign that the sequestered bloodremains sequestered while a clean sample of blood is drawn through thesampling channel. Other visual cues or signs of the sequestration caninclude, without limitation: the air permeable blood barrier turning adifferent color upon contact, saturation, or partial saturation withblood; a color-coded tab or indicator at any point along or adjacent tothe sequestration chamber; an audible signal; a vibratory signal; orother signal.

The sequestration chamber is preferably maintained at atmosphericpressure, and includes a vent 3809 at or near a distal end of thesequestration chamber. The vent 3809 may include an air permeable bloodbarrier as described above. The vent 3809 is preferably located on a topsurface of a housing of the blood sequestration device 3802. The vent3809 and/or air permeable blood barrier can be circumscribed by a wallor other separation mechanism. The vent 3809 can include a cap 3810 as aclosure mechanism.

In some implementations, the cap 3810 can include substantiallycylindrical cap having a closed top end and an upon bottom end. The cap3810 can be tethered to the housing and/or the vent 3809, such as arounda side wall that defines the vent 3809. Alternatively, the cap 3810 canbe formed as a lid that is slid along a predefined track or connectionmechanism from an open position to expose the vent 3809, to a closedposition to cover the vent 3809. In some implementations, as shown inFIGS. 38C and D, the cap 3810 is actuated from an initial configurationto a second configuration, or from an open mode to the closed mode, bymanual capping operation by a user. For instance, a user can push on atop (the closed portion) of the cap 3810 and down onto a “stovepipe”mechanism that constrains the vent 3809, whereby the cap 3810 can“click” or otherwise be locked into place. Alternatively, the cap 3810can be slid from one position that allows the vent 3809 to be exposed toatmosphere, to a second position that covers, encloses, and/or seals thevent 3809.

Accordingly, for an exemplary implementation of the blood sequestrationdevice 3802 in use, a sampling channel and a sequestration chamber areinitially air-filled at atmospheric pressure, but the sampling channelis directed to an outlet port that will be initially sealed by aVacutainer or other such sealed blood sampling device, and thesequestration chamber terminates at a vent to atmosphere that includesan air permeable blood barrier. After a venipuncture by a patient needleof a patient (not shown), which could gather a number of pathogens fromthe patient's skin, a first amount of the patient's blood with thosepathogens will pass through inlet port of blood sequestration device.This initial volume of potentially contaminated blood willpreferentially flow into the sequestration chamber by finding the pathof least resistance. The patient's own blood pressure overcomes theatmospheric pressure in the vented sequestration chamber to displace airtherein through the air permeable blood barrier, but is not sufficientto overcome the air pressure that builds up in the sealed samplingchannel. In various exemplary embodiments, the sequestration chamber andsampling channel can be configured such that the force generated by thepatient's blood pressure is sufficient to overcome any effect ofgravity, regardless of the blood sequestration device's orientation.

Eventually, the sequestration chamber fills with blood that displacesair through the air permeable blood barrier, which may or may not be acomplete barrier or seal against blood. Once the blood contacts the airpermeable blood barrier, the blood interacts with the air permeableblood barrier material to at least partially seal the vent. To augmentsuch seal, or to seal itself, a user can manually move the cap 3810 overthe vent 3809 to enclose, cover and/or seal the vent, and inhibit airfrom reentering the blood sequestration chamber.

While the implementations shown and described in reference to FIGS.36-38 disclose a manual closure mechanism, such closure mechanism mayalso be automatically or remotely controlled, by electronic circuitry,wireless signaling, or even mechanical actuation or biasing. Forexample, a switch in the vent can be actuated by blood sequestered inthe sequestration chamber, or elsewhere in the blood sequestrationdevice, and the switch can automatically actuate the closure mechanismfrom an open position to a closed position. Biasing mechanisms such assprings or levers can be employed to ensure actuation from the open modeto the closed mode of the closure mechanism, particularly if configuredas a cap.

Although a variety of embodiments have been described in detail above,other modifications are possible. Other embodiments may be within thescope of the following claims.

1. A blood sequestration device comprising; an inlet port; an outletport; a sequestration chamber connected with the inlet port, thesequestration chamber having a vent that allows air to be displaced by afirst portion of blood entering the inlet port and into sequestrationchamber; a closure mechanism to enclose the vent to inhibit air fromreentering the sequestration chamber; a sampling channel having aproximal end connected with the inlet port and a distal end connectedwith the outlet port; and a housing that houses and defines the inletport, the outlet port, the sequestration chamber, and the samplingchannel.
 2. The blood sequestration device in accordance with claim 1,wherein the vent includes an air permeable blood barrier material. 3.The blood sequestration device in accordance with claim 2, wherein thevent includes a cap having an aperture, and wherein the closuremechanism includes a flexible sheet positioned between the air permeableblood barrier material and the aperture.
 4. The blood sequestrationdevice in accordance with claim 3, wherein the vent further includes awall that at least partially surrounds the air permeable blood barriermaterial, and wherein the cap at least partially fits around the wall.5. The blood sequestration device in accordance with claim 4, whereinthe flexible sheet is positioned on a top edge of the wall that at leastpartially surrounds the air permeable blood barrier material.
 6. Theblood sequestration device in accordance with claim 3, wherein theflexible sheet is formed of silicone.
 7. A blood sequestration devicecomprising: a housing defining an inlet port, an outlet port, asequestration chamber connected with the inlet port, and a samplingchannel having a proximal end connected with the inlet port and a distalend connected with the outlet port, the sequestration chamber having avent that allows air to be displaced by a first portion of bloodentering the inlet port and into the sequestration chamber such that asecond portion of blood flows into the sampling channel and to theoutlet port, the vent comprising a closure mechanism to enclose the ventto inhibit air from reentering the sequestration chamber.
 8. The bloodsequestration device in accordance with claim 7, wherein the housingcomprises a lower housing member and an upper housing member mated withthe lower housing member.
 9. The blood sequestration device inaccordance with claim 7, wherein the vent includes an air permeableblood barrier material.
 10. The blood sequestration device in accordancewith claim 9, wherein the vent includes a cap having an aperture, andwherein the closure mechanism includes a flexible sheet positionedbetween the air permeable blood barrier material and the aperture. 11.The blood sequestration device in accordance with claim 10, wherein thevent further includes a wall that at least partially surrounds the airpermeable blood barrier material, and wherein the cap at least partiallyfits around the wall.
 12. The blood sequestration device in accordancewith claim 11, wherein the flexible sheet is positioned on a top edge ofthe wall that at least partially surrounds the air permeable bloodbarrier material.
 13. The blood sequestration device in accordance withclaim 10, wherein the flexible sheet is formed of silicone.
 14. A bloodsequestration device comprising; an inlet port; an outlet port; asequestration chamber connected with the inlet port, the sequestrationchamber having a vent that allows air to be displaced by a first portionof blood entering the inlet port and into sequestration chamber; aclosure mechanism to enclose the vent to inhibit air from reentering thesequestration chamber, the closure mechanism including a cap that isconfigured to seal the vent after at least a portion of air in thesequestration is displaced by the first portion of blood; a samplingchannel having a proximal end connected with the inlet port and a distalend connected with the outlet port; and a housing that houses anddefines the inlet port, the outlet port, the sequestration chamber, andthe sampling channel.
 15. The blood sequestration device in accordancewith claim 14, wherein the vent includes an air permeable blood barrier.16. The blood sequestration device in accordance with claim 15, whereinthe vent further includes a wall that at least partially surrounds theair permeable blood barrier material, and wherein the cap at leastpartially fits around the wall to seal the vent.
 17. The bloodsequestration device in accordance with claim 14, wherein the cap isconnected to the vent by a tether.
 18. The blood sequestration device inaccordance with claim 14, wherein the vent includes one or more ventholes.
 19. The blood sequestration device in accordance with claim 14,further comprising a diverter junction between the sequestration chamberand the sampling channel.
 20. The blood sequestration device inaccordance with claim 19, wherein the diverter junction is formed toautomatically direct the first portion of blood into the sequestrationchamber, and to automatically bypass the sequestration chamber with asecond portion of blood directed to the sampling channel.